ANESTHESIA PATIENT SAFETY FOUNDATION
NEWSLETTER

Volume 2, No 3, pp21-28
September, 1987
Table of Contents

Patient Safety At The ASA
N.Y. Would Limit Work Hours, Mandate Patient Monitoring
Plans Outlined to Help Departments Get Needed Safety Hardware
Editorial:  Good News and Bad News on Safety
CA Insurer Notes Fewer Claims, Lower Premiums
From the Literature: Anesthesia Machines Explained
From the Literature: Accident Analysis Points Way to Greater Safety
A Model of Mishap Recovery Problem Solving
Foreign Correspondence: Patient Safety Receives Major Emphasis in Canada
Current Questions in Patient Safety
Notes




Patient Safety At The ASA

A variety of presentations at the October 10-14 ASA Annual Meeting in Atlanta will consider issues related to anesthesia patient safety. Also, there will again be among the exhibits the Patient Safety Booth display sponsored by the ASA Committee on Patient Safety and Risk Management.

Among the Refresher Courses on Sunday, Oct. 1 I will be "Anesthesia Disasters: Incidence, Causes, Preventability" by R. Keenan, M.D., "The Measurement and Maintenance of Oxygen Transport" by K. Tremper, M.D. and "Oxygen Monitoring in the OR: by C. Whitcher, M.D. Further, "Capnography A Useful Clinical Monitor for the Anesthesiologist" will be given by D. Swedlow, M.D.

As part of the Clinical Forum, E.S. Siker, M.D. will present sessions on "Which Monitors and Why" and "Anesthetic Mishaps."

A special meeting on "Standards for Anesthesia Care" will be held 9-11 a.m. Tuesday, Oct. 13.

Among the scientific presentations, there will be three sessions under the heading "Patient Safety and Epidemiology." Oral papers will be presented Monday, Oct. 12 with eight papers in the morning sessions and 11 in the afternoon while there will be poster sessions Wednesday, Oct. 14 including patient safety topics.

Also on Wednesday the 14th there will be a panel discussion on "Monitoring" including consideration of cardiovascular, respiratory, neurological, and obstetrical monitoring as well as presentations on pulse oximetry and "standards and the law."

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N.Y. Would Limit Work Hours, Mandate Patient Monitoring

by David E. Lees, M.D.

New regulations proposed in New York State this summer may radically restructure the traditional way doctors are trained in teaching hospitals in the Empire state and also would mandate intraoperative patient monitoring.

These regulations would be the first in the country to limit residents in training to a maximum of 16 hours on duty without a formal break. Concern about the long hours worked by residents was brought to the fore by the death of an I 8-yearold woman admitted via the emergency room to a large New York City teaching hospital and treated by a first year resident.

A Grand jury empanelled to investigate the death reported last January that the long grueling hours of unsupervised interns and residents led to the death of the young woman. ("Report of the Fourth Grand Jury for the April/May Term of 1986 Concerning the Care and Treatment of a Patient and the Supervision of Interns and Junior Residents at a Hospital in New York County"). The Grand jury made five recommendations and while some of them were specifically directed at emergency room care, several of them will have a direct effect on anesthesia training programs. In particular, the Grand jury stated that "the State Department of Health should promulgate regulations to insure that interns and junior residents... are supervised contemporaneously and in person by attending physicians. . '" In addition "The State Department of Health should promulgate regulations to limit consecutive working hours for interns and junior residents in teaching hospital."

An Ad Hoc Advisory Committee on Emergency Services was then formed by the Commissioner of Health, Dr. David Axelrod to analyze the recommendations of the Grand jury and make further suggestions. The Ad Hoc Advisory Committee was comprised of nine prominent physicians with significant experience in graduate medical education; its report attacked the current entrenched system of medical training and further recommended that "house officers and/or full time attendings, who have direct patient care responsibilities and who work in areas other than the emergency room, shall not in general work for more than 16 consecutive hours per shift; shifts of 16 hours shall be separated by no less than eight hours of non-working time. In no case shall an individual person who has worked the maximum consecutive hours in one hospital, work in a different hospital in a consecutive fashion. Enforcement of this policy shall be the responsibility of the primary employer of the physician. The breech of this policy shall be considered medical misconduct" 'The Ad Hoc Advisory Committee also endorsed the Grand jury's concept of appropriate in-person and timely supervision of resident and intern physicians by attending physicians.

Resident Hours: Experience vs. Fatigue vs. Great New Costs

A recent study conducted in New York City found that residents, on average, work 78 hours per week. Of these 78 hours, 20 are call hours; therefore almost 60 hours are spent in formal work. Those in opposition to the proposed changes stress that illness has no shifts nor 24 hour limitations and that physicians in training need to learn to follow an illness throughout its course. They argue that the long hours toughen young doctors to the rigors of medical practice, expose them to the evolution of a patient's illness and provide continuity of cam They also point out the economic implications of such a radical restriction in training hours. The president of the Greater New York Hospital Association, which represents private non-profit teaching hospitals projected that the rules would cost hospitals "tens and tens of millions" in additional operating costs.

The president of the Committee of Interns and Residents, which represents New York City house staff said that the interns and residents are often asked to fill in for missing support staff because of chronic ancillary staff shortages; they basically provide "cheap labor" for long hours at low wages. Those in favor of cutting the hours argue that with the growing sophistication of medicine, sleep deprivation among house officers has become even more dangerous to patients. The Manhattan District Attorney said the State's proposals "will have a major impact on the quality of care in teaching hospitals... they would make New York hospitals lead the nation in the training of young doctors".

Monitoring Targeted

Besides addressing this "software" issue, the State is also tackling the "hardware" side by proposing new regulations concerning minimum monitoring standards for Anesthesia practice; (New York State Code of Rules and Regulations Part 405.13). Of particular interest are the following two sections: "During the administration and conduct of all anesthesia except locals and epidurals unless medically indicated, the patient's oxygenation shall be continuously monitored to ensure adequate oxygen concentration in the inspired gas and the blood through the use of a pulse oximeter" and "For every patient receiving general anesthesia with an endotracheal tube, the quantitative carbon dioxide content of expired gases shall be monitored through the use of end-tidal carbon dioxide analysis".

Regs Could Open "Purse;" Questions Remain

Despite the cost of at least $10,000 per anesthetizing location to achieve compliance with the proposed regulations, most of the anesthesia community appears to be in agreement with the proposed standards. In a sense it "holds a Sun" to the heads of hospital administrators and forces them to loosen the budgetary purse strings. Criticism has focused on the fact that while the capnometry proposal supports a performance standard, the oximetry standard is a design standard mandating "pulse oximetry" rather than arterial saturation. Such a design-based standard can quickly become obsolete as better methods to measure Sao2 come on the market.

The recommendations of the Commissioner of Health are usually followed by the Hospital Review and Planning Council which allows for public comment. The Council is an arm of the State Department of Health that is empowered by the Legislature to regulate hospital physician-training programs in New York because their cost is borne by the public in the form of higher public and private insurance rates. It is expected that the rules could take effect as early as January 1988.

Dr. Lees is Professor and Chairman of Anesthesia, New York Medical College and an AFSFAC-newsletter Editorial Board member.
 

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Plans Outlined to Help Departments Get Needed Safety Hardware

by William Cass, A.R.M.

In response to questions by anesthesia care providers on how to best convince those responsible for capital equipment expenditures in their institutions to fund purchase of modern anesthesia patient monitoring equipment, the following set of strategies was devised. The original recommendations referred to the malpractice insurance premium discount of 20% offered by the Massachusetts JUA to anesthesiologists who consistently use pulse oximetry and capnography as part of their compliance with the ASA Standards for Basic Intraoperative Monitoring, but the list here has been generically modified to apply nation-wide.

Strategies to Obtain Monitoring Equipment

1. The anesthesiologist should consider developing some kind of plan to avoid a fragmented, delayed request and approval process. The plan should identify the key players, particularly those individuals who have the authority to make decisions and approve the purchase of equipment. The degree of plan formality will vary from institution to institution according to the degree of resistance anticipated, i.e.; the greater the anticipated resistance, the more formal the plan.

2. The anesthesiologist alone should not attempt to secure the monitoring equipment. Traditionally, surgeons have power within the Medical Staff organization and hospital administration/corporate management group. For a surgeon, few occurrences are more devastating than performing successful surgery and then discovering that the patient has suffered a serious and/or permanent anesthesia related injury. The surgeon has a vested interest in anesthesia safety and is a natural ally. Gain the support of the Department of Surgery and other influential members of the Medical Staff.

3. The process of gaining administrative/corporate support and approval of the monitoring equipment request should be non-demanding, non-threatening and free of ultimatums. Emphasis should be on the education of management individuals who will make the decisions. The benefits, logic and importance of the monitoring equipment is self-evident and will sell itself if properly presented. Prior to initial discussions with administration/management, the anesthesiologist should provide written material designed to educate. The material should include, but not necessarily be limited to; ASA Standards, Harvard Standards, Board of Registration in Medicine Regulations if applicable, monitoring equipment information, Ward and Cheney Claim Analysis Study, and any pertinent information from the involved malpractice insurance carrier. If there is a great volume of material, consider sending it to management in two or three packets spaced several days apart. There is a greater probability of management seriously reviewing it if the quantity is reasonable and the material can be reviewed in a short period of time

4. There is a possible marketing advantage for those institutions who offer the most up-to-date clinical equipment, particularly clinical equipment designed to decrease the probability of catastrophic injury. At the very least, use of the monitoring equipment will prevent a competing institution from gaining a marketing advantas. Both patients and surgeons are very much aware of anesthesia risks and will base their decisions on where to receive or provide anesthesia care at least in part on safety factors. For institutions not providing readily available monitoring equipment, a decrease in surgical admissions is not a remote possibility. Ask anyone, including administrators and managers, "If you were to have general anesthesia tomorrow, would you want a pulse oximeter and C02 analyzer used in your anesthesia care?"

5. There will be no question that the absence of the anesthesia monitoring equipment wig adversely effect the ability of the institution to recruit anesthesiologists and CRNA!S.

6. Note in detail any possible lowered insurance premium incentives (such as in Massachusetts). At the very least, the premium discounts and eventual lowering of insurance classifications will help stabilize and/or slow the rate of increased anesthesia costs. Everyone including anesthesiologists, patients, and administration/management will benefit from the decreased cost of anesthesia care.

7. Anesthesia monitoring equipment (particularly the pulse oximeter and C02 analyzer) constitutes a safety "breakthrough" equivalent to electronic cardiac monitoring in terms of potential for preventing catastrophic outcomes of care. As no one should consider providing cardiac care without an EKG monitor, no one should consider providing anesthesia care without a pulse oximeter and C02 analyzer readily available. The cost vs. benefit equation for anesthesia monitoring equipment is highly favorable and significantly greater than the vast majority of more expensive clinical equipment commonly found in hospitals. One can always provide the benefit of something such as CAT Scan by sharing services with other hospitals, but the only way one ran provide the benefit of anesthesia monitoring equipment is to purchase or lease it.

8. It's safe to say that all future anesthesia malpractice cases will be judged against a standard that includes pulse oximetery and end-tidal C02 monitoring. Any anesthesiologist/CRNA and hospital not using or providing such equipment will be in a very difficult situation in terms of defending themselves in any future anesthesia malpractice claim. Dr. Howard Zauder, ASA President, contends that "the courts have made the pulse oximeter a basic standard in liability litigation, even though the new ASA Standards list it only as one of several options in monitoring circulation".

9. With increasing frequency, hospital negligence, questions of negligence, and unfortunate outcomes of care become widely known via the media. Catastrophic anesthesia injury without the use of anesthesia monitoring equipment has a higher than average probability of be-coming publicly known. Dollar loss via malpractice claim will be covered by liability insurance, but the damage to a hospital's and anesthesiologist's public reputation is an uncovered loss and usually takes years to repair. In many cases, it is much more serious than dollar loss because it negatively effects staff recruitment, staff morale, in-patient/out-patient census and the hospital's relationship with accrediting and licensing agencies.

10. Anesthesiologists should seek the assistance of the hospital administration/corporate management and other anesthesiologists in exploring

group/volume purchase arrangements to reduce total costs to absolute minimums.

11. Medical malpractice insurance companies' Risk Management Services are available to assist the anesthesiologist in his/her efforts to improve anesthesia safety whenever necessary.

Mr. Cass is Manager, Risk Management Services, joint Underwriter's Association of Massachusetts. Also participating in the development of the strategies were Mssrs. Nils Maurice and Gerald Cassidy of the JUA and Drs. Joseph Beauregard and Gerald Zeitlin.

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Editorial:  Good News and Bad News on Safety

For several years, anecdotal evidence has strongly suggested that the incidence of anesthesia mishaps in the United States, as well as other countries, is declining significantly.  In the December, 1986 issue of the APSF Newsletter, Mr. Mark Wood of St. Paul Insurance Company provided data supporting this premise.

Again, in this issue, information from the Doctors' Company in California provides additional support.  Moreover, several insurance companies have lowered the anesthesiology premium relativity recently.  CRICO, the Harvard company, has reduced anesthesia from 5.0 to 4.0 and the Massachusetts Joint Underwriting Association has tentatively planned to lower, in the remainder of Massachusetts, the relativity from 5.0 to 4.0 in 1988, to 3.5 in 1989, and to 3.0 in 1990.  The latter three reductions would result in a combined decrease in premiums of about 35%, this on top of the some 20% discount for anesthesiologists promising to utilize pulse oximetry and end tidal PCO2 measurement whenever possible.

On a sour note, in recent months it has come to my attention that certain anesthesiologists use no instrument monitoring whatsoever, not even an EKG, and frequently leave the room with a patient on a ventilator unattended by an anesthesia person.  It has also come to light that far too frequently the state of anesthesia apparatus is grossly inadequate.  I ask you, who are interested in furthering safety, what can we do to turn around these last two situations?

Ellison C. Pierce, Jr., M.D.
President
Anesthesia Patient Safety Foundation

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CA Insurer Notes Fewer Claims, Lower Premiums

by Joseph D. Sabella, M.D.

This discussion considers the medical malpractice problem from a perspective that is only a dozen years old and is the hybrid offspring of the marriage of medicine and insurance. The origin of this union was Malpractice Crisis Number One of the mid'-70s, brought about by the shrinking availability of insurance as commercial insurers Red the marketplace, and by decreasing affordability as others raised premiums to startling multiples of three, four, and even five times the previous levels.

An important outgrowth of Crisis Number One was the creation of a number of doctor-owned medical malpractice insurers throughout the country. These now number 40 at last count and insure more than half of all practicing physicians. In 1976, an unknown wag labeled doctor-owned insurers, somewhat indelicately and disparagingly, Bedpan Mutuals.

Our company, The Doctors' Company, is an interinsurance exchange owned by its members and is the offspring of a political action group organized early in 1975 that was called the California Physicians Crisis Committee (CPCC). The CPCC created a coalition of medicine, business, labor unions, the aged, welfare groups and consumer organizations, and it was this coalition that served as the catalyst for the enactment in the fall of 1975 of the reforms of California law pertaining to medical malpractice.

Anesthesiology was a specialty in severe crisis 12 years ago. Premiums were skyrocketing and no end seemed to be in sight. In 1975, we created an endorsement for the policies of our anesthesiologists that required two simultaneous methods of basic intraoperative monitoring, temperature monitoring in children, and forbade the anesthesiologist from leaving the room unless someone of comparable competence took his or her place.

Moreover, anesthesiologists themselves recognized that they would have to participate in controlling their own loss experience if they were to remain an insurable specialty. Their participation reached its logical conclusion last year when the American Society of Anesthesiologists created concrete, sophisticated standards of practice for intraoperative monitoring for its membership. We are currently in the process of incorporating the ASA's standards into our own anesthesiology policy endorsement.

There have been major improvements in anesthesia claims, which has resulted in a relative decrease in malpractice insurance premiums for anesthesiologists. In 1976, our over-all average premium was $9,743 and the premium for anesthesiologists was $15,389. In sharp contrast, in 1987, the over-all average physician's premium in California is $19,597 but that for anesthesiologists is only $16,199. The insurance cost to anesthesiologists, which is now substantially below our average premium, reflects a remarkable turnaround in anesthesiology's loss experience.

Dr. Sabella is President and Chairman of the Board, Re Doctors' Company. This article was excerpted from a presentation, "Composite Medical and Insurance View of the Professional Liability Problem", given at the 27th Annual Conference of THE AMERICAN COLLEGE OF LEGAL MEDICINE, March 7-9, 1987, Long Beach, California.

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From the Literature: Anesthesia Machines Explained

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

Petty, Clayton, M.D., 7he Anesthesia Machine. Churchill Livingstone, New York, Edinburgh, London, Melbourne, 1987.

This book is an important addition to the literature examining the anesthesia machine and its safe use. As noted by Burnell R. Brown, Jr., M.D., in the Forward to the book " insight into the components and circuitry of the machine is not only important from a purely academic viewpoint, it can save lives".

In his Preface, Dr. Petty says, "I have attempted to provide information in the form that wig be easily understood by anesthesiologists in private practice, medical students, nurse anesthetists and residents" ' In my view, he has successfully accomplished his S".

In the twelve chapters, the author reviews the history of the development of anesthesia machines and their current manufacture. He succinctly describes flow meters, vaporizers, carbon dioxide absorption, anesthesia circuits and scavaging. He also thoroughly examines compressed gases, pressure regulators, and piping systems. There is, appropriately, a separate chapter examining anesthesia ventilators.

From the viewpoint of the Anesthesia Patient Safety Foundation, the last two chapters are perhaps the most important. They are entitled, "Safety Features of the Anesthesia Machine' and "Risk Management and Quality Assurance for Anesthesia Machines".

I encourage all departments of anesthesia to secure this volume for their library and add it to the current crop of books on the subject, described periodically in this Newsletter.

Abstracted by: Ellison C. Pierce, Jr., M.D., Harvard Medical School, President, Anesthesia Patient Safety Foundation.

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From the Literature: Accident Analysis Points Way to Greater Safety

Editor's note: In the APSF Newsletter, pertinent publications from the anesthesia patient safety literature will be summarized. Suggestions for future issues are welcome. For this very important, special, and complex paper, the first author was asked to provide a summary.

Gaba DM, Maxwell M, DeAnda A; Anesthetic mishaps: Breaking the chain of accident evolution. Anesthesiology 66:670-676, 1987.

This paper presents a new framework for looking at anesthetic mishaps. The approach comes from work concerning other high-risk industries published by the organization theorist, Dr. Charles Perrow (Normal Accidents, New York, Basic Books, Inc., 1984).

Accidents continue to occur in high-risk industries in spite of multiple technological and organizational fail-safe systems. Such mishaps are called "system accidents" in that they involve unanticipated interactions or multiple failures throughout the "system' " This concept appears to describe many anesthetic mishaps where a combination of circumstances leads to disaster.

Complexity and Coupling

The elements that make a system accident more likely are complexity of interactions and tight coupling between components or sub-systems. Complexity arises in anesthesia because of uncertainty about physiologic and disease processes in individual patients, and because of the limited means available to assess and monitor these processes. Tight coupling arises when a simple failure has immediate serious effects (e-g. drug swap), or when it directly induces failures in other systems (e.g. pneumothorax leading to hypoxia and cardiovascular compromise).

The failures, errors, and abnormalities which routinely occur during anesthesia may be called simple incidents, and they can arise from the patient's diseases, from the surgery, or from the anesthetic or anesthetist. The anesthetized, paralyzed, and mechanically ventilated patient is a tightly coupled system which involves complex interactions of human physiology and anesthetic equipment. In this setting a simple incident can easily progress to a critical incident, previously described by Cooper, et al. as one which could lead directly to an adverse patient outcome. If the critical incident is not detected and corrected, a substantive negative outcome is likely, thus yielding an accident.

Recovery from Incidents

Since simple incidents are common, patient safety often depends on the process of recovery from the incident. Spectacular failures in several high-risk industries remind us that successful intervention in the chain of accident evolution cannot be guaranteed. The recovery process involves complex problem solving skills which are just beginning to be investigated (see figure).

In the past, anesthetic mishaps have been largely attributed to a lack of vigilance. But at least one third of critical incidents studied by Cooper's group involved other mental errors with perfectly adequate vigilance, and it is likely that combinations of such human failures are at the heart of most mishaps. Vigilance is thus a necessary but not sufficient condition for averting accidents. This has some bearing on recent trends in anesthetic practice, since the assumption that detection of an incident by new monitors or "vigilance aids" will necessarily lead to successful recovery from the incident is not proven. The contribution of monitoring to patient safety depends on the ability of anesthesiologists to use the data correctly in a setting likely to be full of artifact or contradictory information.

Experience in other industries suggests that available data is not always used wisely. A critical factor is the operator's mental map of the situation. Instrument readings are accepted based on their conformance to the current map. Abnormal readings may be rejected, even when true, due to mistrust of instruments that are prone to failure or artifacts, as was the case at Three Mile Island and in several commercial aviation accidents. Monitors or alarms may be purposefully turned off for the same reasons.

Pressure to Produce

An additional key factor present in most industrial accidents is the pressure to produce. The temptation in anesthesia to "cut corners" is great, and potential hazards may be ignored because of complacency induced by the usual safety of "routine" cases. Other industries have established formal procedures governing decision-making under pressure. NASA's set of Flight Readiness Reviews, Launch Commit Criteria, and Launch Constraints should have prevented the Challenger disaster; it was the disregard of these established procedures that led to catastrophe. Anesthesiologists also usually do a pre-operative readiness review of patients before anesthesia, but firm, objective guidelines for when to proceed or to cancel or abort surgical procedures CIO not exist, and great pressure may he exerted to "bend the rules" to get the cases done. We suggest that a local consensus be sought among anesthesiologists, surgeons, internists and pediatricians in each institution to establish or strengthen these ground rules.

False Security

Furthermore the temptation to use "safety technology" as a means to speed or expand production must be avoided. A false sense of technological security has led to more near misses in aviation, the launch of the Challenger in unprecedentedly cold weather, and the Chernobyl disaster. New instruments for anesthesia should be used first and formost to enhance safety, and only very cautiously to allow techniques or procedures that might have previously been considered too hazardous.

There is no easy technological fix for maintaining or enhancing anesthesia patient safety. Safety involves much more than just the vigilant application of modem monitoring equipment. Aviation was made acceptably safe only by a system that provided intensive research on fundamental aerodynamics and aircraft design, centralized air-traffic control, and a large regulatory bureaucracy. There are numerous elements in the "larger system" of anesthesia which may paradoxically provide negative incentives for safety, or even positive incentives for clearly unsafe actions. Perrow terms this an "error inducing system:' The incentives and constraints of this larger system determine to what extent anesthesia patient safety can be improved.

In summary, anesthesia is a risk for all patients. Though research and technology may reduce the uncertainties of administering anesthesia, incidents and errors are inevitable and attention should focus on recovery from error as much as preventing errors. Therefore, recommended are:

1) Improving the detection of simple incidents: newer monitors can detect life-threatening failures at an earlier stage, and the actual contribution of these devices should be clearly established. Alarms and displays can be improved, although the optimum design is not yet clear.

2) Improving the abilities of anesthesiologists to develop effective problem solving skills using good mental maps of the case in progress. Simulators should be developed to enhance training in the handling of simple and critical incidents.

3) Defining the necessary back-up equipment and procedures for common mishaps, and common surgical situations.

4) Cataloging and disseminating effective protocols for handling rapidly evolving incidents, as has already been done for malignant hyperthermia. Such recovery processes should be practiced using simulators.

Go/No-Go Decisions

5) Easing production pressures to allow increased attention to pre-operative checks, readiness review of patients, and proceed versus cancel decisions. Consensus among providers should be sought to avoid misunderstandings which can only detract from patient safety.

Anesthesiologists are the most important link in the chain of safe anesthetic cam We have a responsibility to scrutinize our own abilities and limitations as carefully as we investigate those of our drugs and tools. We must define and implement the procedures and training which can be shown to optimize patient safety. Furthermore, we must steer the interacting sources of incentive and constraint towards a system that consistently promotes patient safety. The path to this goal has yet to be defined, but the public, the courts, and the regulatory and accrediting agencies expect no less. Our profession must take the initiative to see that it is so.

Abstracted by David M. Gaba, M.D., Assistant Professor of Anesthesia, Stanford University School of Medicine.
 

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A MODEL OF MISHAP RECOVERY PROBLEM SOLVING

The recovery process after a simple or critical incident begins with an observation.. Vigilance is essential so that new data are not missed. The new observations must be verified, since there are artifacts and transients which may obscure true findings. Verified data then must be recognized as representing an actual, or potential problem. Failure to do so may result from lack of understanding of what could be problematic, or from complacency generated by the usual "safe" routine. As some problems are more critical than others, an assessment of the importance of a problem is necessary. This assessment will influence how quickly the problem is addressed, and how much additional verification may be needed. It will also determine whether generic failure compensation solutions are immediately required. Most practitioners know what to expect in various situations, and generally have a "list" of expected problems. Initial ideas for responding to actual or potential threats are usually drawn from this list.

Occasionally another problem mimics one on the list, which can lead to faulty decisions.

Solutions are classified as GENERIC -that is they are broad in scope and without specific etiologic foundation, or SPECIFIC -based on specific etiologic hypotheses or knowledge. Generic solutions generally attempt to provide "failure compensation" and to buy time until specific diagnoses and solutions can be definitively implemented. Errors can occur in implementing either generic or specific solutions, and these errors will generate new problems to be solved. The final, and most important step in the process is the re-evaluation of the original problem, its current status, and any additional outstanding problems requiring solutions. Assuming that a problem has been solved without double-checking can lead to catastrophe, and solving one problem may not eliminate the threat to the patient.
 
 

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Foreign Correspondence: Patient Safety Receives Major Emphasis in Canada

by Ian M. Davies, M.D., FRCPC Foothills Hospital at the University of Calgary Calgary, Alberta, Canada

When the International Committee for Prevention of Anesthesia Mortality and Morbidity (ICPAMM) met in Vienna in September, 1986, one of the aims was to hear reports from participating countries. In my report from Canada, I emphasized the geographic isolation that afflicts those of us ,north of the 49th. For example, only 16% of the population of 26,000,000 lives in six major cities. The effect on anesthetic resources and manpower of such a low density/widely distributed population has been termed the 'tyranny of geography, and applies also to other countries, e.g. Australia. Thus, although health care practices in Canada and the United States are similar and we perceive that our anesthetic standards should be equal, differences in the financial resources of the two countries mitigate against such equivalence.

However, in general, the standard of anesthetic care in Canada is high. All anesthetists are physicians although the length of training is highly variable. The specialist degree requires internship plus four years of residency. Anesthetic equipment is also well regulated, with the Canadian Standards Association (CSA) having established the first, comprehensive standard for anesthesia equipment.

Since the ICPAMM meeting, developments have occurred in five areas of anesthetic safety.

First an anesthesia manpower survey is underway. The study was organized by the Manpower Committee of the Canadian Anesthetists Society and chaired by Dr. Charles E. Hope, Dalhousie University. It is contributing to the National Manpower Study of Physicians organized by the Canadian Medical Association and the Royal College of Physicians and Surgeons of Canada.

The purpose of the study is to determine who practices anesthesia and in what capacity (full or part time). Stage one of the study involved validating the names and specialties of physicians involved in Canada. The results for anesthesia will be given in a final report to the executive of the Canadian Anesthetists' Society and the Association of Canadian University Departments of Anesthesia by early August, 1987. Stage two of the study will identify factors which influence future manpower requirements, e.g. lifestyle factors.

Second, in the spring of 1987, the Canadian Anesthetists Society published its Guidelines to the Practice of Anesthesia. 1 This booklet covers such topics as organization of hospital anesthesia services, privileges, residents, auxiliary help, anesthetic equipment, records, and patient monitoring. However, there is no mandatory requirement for monitors of oxygen delivery or patient oxygenation.

Third, despite the lack of requirement of oxygen monitors, many anesthetists think that the pulse oximeter is an absolute necessity. Some have felt so strongly they have held their hospitals virtually to ransom, requiring the purchase by a certain date or threatening closure of operating theaters. Other anesthetists have chosen to add the monitors to the budget, acquiring each one as SC 8,000 becomes available.

Fourth, the problem of ever-increasing malpractice insurance fees is of concern. For example, the Canadian Medical Protective Associa6on last year assessed fees of some SC 60,000,000 to cover about 48,000 doctors. 2 Yet there is a low incidence of malpractice suits, and no epidemic of litigation.

Safety Studies Underway

Fifth, there are three major studies pertaining to anesthetic safety. The International Multi-Center Study of General Anesthesia is now at the stage of final data analysis. This study involved 15 hospitals in North America (three in Canada) and examined 17,201 patients undergoing a general anesthetic. Patients were randomly assigned to receive halothane, enflurane, isoflurane or fentanyl. According to the Chief Investigator, Dr. I.B. Forrest, McMaster University, the study has shown "significant differences in risk associated with specific systemic diseases; we need to reevaluate the way we assess risk" -He added that "the ASA score is not enough" and that he is developing a new risk index, that is "more meaningful with respect to actual risk" '

A second study involves investigators at the University of Western Ontario (Dr. WA. Tweed), University of Saskatchewan (Dr. P. Duncan) and the University of Manitoba (Drs. Marsha Cohen and W Pope). The objective is to develop a practical system for anesthesia outcome audit, with two aims:

(a) to establish surveillance of d postoperative patients, so as to determine rates of major and minor complications and mortality, and

(b) to allow in-depth review of cases of major morbidity and mortality, using a critical incident approach.

Dr. Cohen received $US 35,000 from the Anesthesia Patient Safety Foundation for the preliminary stages of this project which is now funded ($C 187,000) by the National Health Research Development Program, under the aegis of the federal government.

The third study concerns the selection, training and assessment of anesthetic residents, by Drs. J.M. Davies, Department of Anesthesia, Foothills Hospital at the University of Calgary, and Ed Boyd, Department of Psychology, University of Calgary. As of July 1987, all anesthetic residents entering training programs will be surveyed for the next four years, with respect to demographics, attitudes to anesthesia, and psychological self-assessment. The study population also includes trainees in Eire (August, 1987) and France (May, 1988). The purpose of the study is to examine those individuals now entering the specialty. Because human error is the most important cause of poor anesthetic outcome, the root of the problem may lie with selection and training of anesthetists. Also, as inexperience, fatigue, and pressure of work all contribute to anesthetic accidents, the training programs and their directors will be similarly examined.

References:

1. Guidelines to the Practice of Anesthesia; Canadian Anesthetists' Society, 187 Gerrard Street East, Toronto, Ontario M5A 2E5.

2. Canadian Medical Protective Association, Eighty-Sixth Annual Report August 1987; P.O. Box 8225, Ottawa, KIG 3H7.
 
 

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Current Questions in Patient Safety

Question: "In most groups and departments, are anesthetists giving anesthesia during the workday after they have been on night call and up working; how do you evaluate whether they may be fit to do so or is working the next day no longer even considered?"

Answer: "Fitness" to administer anesthesia is difficult to assess, define, evaluate, or measure. The ability to administer anesthesia safely requires alertness, vigilance, reflex action and reaction, knowledge and psychomotor skills and coordination. How do we determine "fitness" in the anesthesiologist who has been on call the previous night? Is it obvious by appearance after sleeping in the on-call room? Is it related to age or physical fitness? Can it be assessed by language skills? One could go on ad infinitum asking similar questions, all of which would have the same negative answer.

History is replete with episodes of catastrophic occurrences which have been attributed, after the fact, to fatigue and "human error". This is true in anesthesiology as well as in flying, driving, machine work, etc. The most recently publicized event in health care appeared in the news media and related an unfortunate medical outcome to the house officers' fatigue and work schedule. The "effects" of inadequate sleep in an anesthesiologist have only been speculating.

Two straightforward episodes will serve to demonstrate the anecdotal character of the evidence that sleep deprivation is a cause of critical incidents in anesthesia. The first was a patient who was anesthetized for a laminectomy and fusion of the back. The patient had become progressively more hypotensive and the young anesthesiologist was unable to determine the cause. He requested some help to provide a "fresh look" and, indeed, it was pointed out by the anesthesiologist responding to the call that over two units of blood had been lost and this loss had been unrecognized and not replaced. The second episode was a 26 year-old patient who experienced a cardiac arrest during the middle of a breast biopsy under general anesthesia. Cardiac activity was restored when a hypoxic mixture of nitrous oxide and oxygen was recognized and corrected. Both of these episodes occurred under the aegis of two very fine physicians who are extremely capable, intelligent, and excellent clinicians. But in each circumstance, the physician had been "on call" and awake most of the previous night.

In view of sporadic reports of catastrophic occurrence allegedly related to fatigue, sleep deprivation or long continuous periods of work, moderately uniform practices have evolved. In most of the departments with which I am familiar and in which the numbers of personnel allow this, anesthesiologists are relieved of clinical responsibilities the day after having been on call. This practice is not based on any hard objective data relating to the practice of anesthesia per se, but rather is in recognition of the requirements for providing safe anesthetic care, and also in recognition of human and social needs and values of anesthesia care providers. This becomes somewhat of a problem in departments where there are only one or two anesthesia providers and more than a minimum number of anesthetizing locations. Nonetheless, I abhor the practice of disregarding fatigue or sleep deprivation in order to expedite a schedule which has not considered the status or the number of professional personnel available.

It is impossible to generalize on this subject. There are many factors involved in one's ability to function efficiently and safely for prolonged, uninterrupted periods-physical stamina, motivation, basic personality, etc. However, in general, the average individual exhibits some decrement in performance with prolonged periods of uninterrupted or repetitive activity, or with sleep deprivation. This has been reasonably well documented in the literature. 1-5 Many of the studies were carried out with volunteers or paid subjects in the laboratory. As a result, it is impossible to extrapolate these findings directly to the practice of anesthesia wherein motivation, expectation, and incentives play a major role. Nonetheless, the evidence is mounting that among professionals, motivation and incentives notwithstanding fatigue certainly must have a negative effect on performance in the average individual. This is the basis for the practices referred to above in which any individual who has been on call is relieved of clinical responsibilities the following day.

I would like to suggest that the more cogent questions to be addressed are "For how long a continuous period of time should an anesthesiologist administer anesthesia or supervise the administration of anesthesia?" and "Is a 24-hour stretch of duty for an anesthesiologist or anesthetist too long a period of continuous work for safety9" These are questions that must be addressed soon and before any further evidence of relating fatigue to morbidity or mortality develops.

References

1. Teichner WH. 'Me detection of a simple visual signal as a function of firm of watch. Human Factors 1974; 16:339-353.

2. Riemersma JBJ, Sanda3 AF, Wildervark C, Gaitland AW. Performance decrement during prolonged night driving In Mackie RR Ed. Vigilance: Theory, operational performance and psychological correlates. Plenum Press, New York 1977.

3. Lisper HO, Kjellberg A. Effects of 24- hour sleep deprivation on rate of decrement in a ten minute auditory reaction time task. J. Exper Psych 1972; 96:287-290.

4. Morgan BK Brown BR, Alluisi EA. Effects on sustained performance of 48 hours of continuous work and sleep loss. Human Factors 1974; 16:406-414.

5. Paget NS, Lambert TF, Sridhar K. Factors affecting an anesthetist's work: Some findings on vigilance and performance. Anaesth Intens Care 1981; 9:359-365.

Answer by George E. Battit, M.D., Vice Chairman, Department of Anesthesia, Massachusetts General Hospital, Boston.

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Notes

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