ANESTHESIA PATIENT SAFETY FOUNDATION
NEWSLETTER

Volume 3, No. 1, pp. 1-8 March, 1988
Table of Contents

Insurer Studies, Cuts Risks
World Congress in May To Feature Anesthesia Safety
Editorial: The Foundation Turns Two
Monitoring Seen Cost-Effective in Injury Prevention
ASA and CDC Plan National Study of Anesthesia Outcome
From the Literature: New Mortality Study
Letter to the Editor: Wandering Anesthetists
Additional ASA Patient Safety Videotapes Completed
From the Literature: Death During Spinal
Letters to the Editor
APSF Membership Procedure for ASA Members
Major Evaluation of Equipment Published
Notes




Insurer Studies, Cuts Risks

by Paul DeBruine, M.D. and Judith A. Napier, MSN

In the September 1987 issue of the APSF Newsletter, "accident analysis" was discussed by Dr. David M. Gaba. The summary of his work not only addressed several factors that have been identified as increasing accident rates in general as well as in anesthesia practice, but also provided several reasons for system failures and/or accidents (for example, multiple fail-safe mechanisms providing a false sense of security).

In 1985, MMI Companies, Inc., a professional liability insurance carrier, recognizing the spiraling malpractice crisis, developed an anesthesia risk modification program that focused on clinical practice patterns which lend themselves to system failures, accidents, and potential liability exposures. The program addressed systems, issues, and standards in anesthesia practice.

The intent of the program was both to identify practice patterns and change undesirable practices with the goal of improved patient care and decreased liability exposure. In addition, the program was designed to assist in developing an effective defense against allegations of negligence, should an adverse outcome or patient injury occur.

Closed anesthesia claims were examined, and high liability exposure practice patterns were identified. The frequency and severity in terms of insurance pay-out were trended to determine the relationship of the two. Severity was correlated to patient outcome. The claims review revealed that more than 50% of dollars paid went to claims with the allegation of "failure to monitor".

A further analysis of the "fa4ure to monitor" issues revealed high exposure in all are-as of anesthesia practice, including:

* pre-anesthesia evaluation

* intra-op attendance and equipment to monitor patients

* post-anesthesia recovery and follow-up

Other allegations of significant frequency that were identified are listed below in ranked descending order of severity:

* Improper administration of anesthesia"

* Intubation and IV related

* Improper positioning

* Equipment related

Following the claims review, a task force comprised of practicing anesthesiologists from around the country was assembled. This group provided input into the development of a risk modification program to address the allegations identified in the claims review process.

One essential element of the program that the task force identified was the need for leadership in anesthesia departments to provide directions and facilitate change in warranted areas. It was felt that focused leadership is critical to reducing claims in anesthesia.

The Anesthesia Risk Modification Program

The task force drafted guidelines which outline practices that contribute to the effective management of liability exposures related to the provision of anesthesia services. The guidelines address the responsibilities of the Director or Chairperson of the Anesthesia Department, credentials of anesthesia staff, anesthesia equipment, and patient care issues in pre-, intra-, and post-anesthesia areas. They were designed to set minimum goals that an anesthesia department would strive to achieve.

These guidelines form the foundation of a three part comprehensive risk modification program developed to identify, monitor, and mitigate risks associated with anesthesia practice. The three parts of the program are designed to provide data on compliance with the guidelines, on-going monitoring of statistics, and clinical case review.

1. Self Audit Questionnaire

The self audit questionnaire is completed by the Director of the Anesthesia Department. It allows an assessment of the anesthesia services compared to the program guidelines. The results of the self audit assist risk management efforts to modify practice patterns that have been identified as potential risks in the department. An annual review and repeat of the self audit questionnaire allows the Risk Manager and Director of the department to recognize change in the practice patterns of the department.

2. Statistical Data

An ongoing assessment of the department occurs through the use of a criteria-based statistical form. This tool is comprised of volume and outcome criteria that categorize department activities.

Volume statistics (e.g. general and conduction anesthetics in out-patients vs. in-patients) provide the department with a means to review staffing patterns, peak load times, and patterns in utilization.

Outcome indicators, such as deaths, cardiac arrest, neurological or peripheral nerve injuries, etc., provide the Director of the department with a snapshot view of the number of "serious patient outcomes" that have a high potential for claim consequences. The patient outcome information is collected on a monthly basis and submitted into a national data bank. Again, the statistical information is designed to provide a mechanism for liability-focused clinical risk modification, as opposed to a traditional process-oriented quality assurance program.

3. Clinical Case Review

A mechanism was established to provide insight into cases that meet a serious outcome criterion or had a higher degree of loss exposure (increased potential severity). This step has become the most beneficial and valued mechanism in the process.

Specific outcome indicators were identified for required review by the departments involved. In general, required review is expected in cases that resulted in actual or potentially liable situations and the goal is to minimize both. For example, any time a cardiac arrest occurred, the case was intensively reviewed. If the outcome was due to an anesthesia related factor, a detailed in-depth review of the anesthetic occurs. This system of clinical case review allows a follow-up mechanism that goes beyond the mere numbers collected on a monthly basis in the statistical form.

The importance of the clinical case review rests on the process and goal of the process. The key point of the review mechanism is the focus on issues of safety in practice, not on discipline of practitioners. Issues raised need to be addressed and resolved. Adverse trends identified lead to changes intended to prevent future recurrences. The result of this effort is improved patient care.

The clinical case review process allows the interaction of people from the multiple disciplines involved with perioperative patient care. The perioperative committee, therefore is comprised most often of the Medical Director of Anesthesia, Medical Director of Surgery, Nursing

Managers of OR and PACU, CRNA, and the Risk Manager. This committee functions as the anesthesia "risk management" committee. The group works directly with the hospital risk manager to set into motion activities to modify identified risk exposures.

Early Results

This approach to anesthesia risk modification has been in operation for 18 months. While the program is very young, early results are encouraging.

* The number of anesthesia departments instituting a perioperative committee or an interdepartmental, interdisciplinary patient care committee has increased considerably.

* Numerous hospitals have reworked the anesthesia record. The clinical case review has prompted the supported positive changes in these records because the review process needs a clear, detailed chronology of events to work with.

* Some significant changes are occurring in equipment. Departments are examining their old and outdated equipment and slating it for replacement. Administrations are supporting these efforts since, again, the emphasis is on reduction of exposure practices that may increase insurance pay-out.

* A recent credit system was initiated for anesthesiologists using pulse oximetry and capnography.

* One significant change is in departmental leadership. Department he-ads have been assigned the additional responsibility of assuring that all members of their departments are quality care providers, which includes risk conscious practitioners.

In essence, the risk modification program described here is a risk management program for the anesthesia department. A risk management approach that is squarely set on prevention. Patient protection and consequent protection of the anesthesia practitioner is its ultimate goal.

Dr. DeBruine is Chairman of the Anesthesia Department at Decatur Memorial Hospital, IL and Medical Consultant to MMI Companies, Inc. Ms. Napier is Assistant Director, Risk Management and Manager, Physician Services at the MMI Companies, Inc.

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World Congress in May To Feature Anesthesia Safety

The ninth World Congress of Anesthesiologists will be held in Washington, D.C. May 22-28. This meeting is co-sponsored by the World Federation of Societies of Anesthesiologists and the ASA and is expected to attract many practitioners from around the world. The theme of the

Congress is "vigilance".

There will be a refresher course given by APSF President E.C. Pierce, M.D. on "State-of-the-art monitoring in anesthesia". Panels with distinguished international participants will be held on "Anesthesia patient safety" and "Anesthesia outcome and quality assurance. how do we measure it and does it influence care?" In addition, there will be sessions of scientific papers in the area of "Patient Safety and Risk Management."

Throughout the Congress, the Anesthesia Patient safety Foundation will maintain a booth among the exhibits. In addition to general information, there will be available bound volumes of the APSF Newsletter, the videotape "Safety and Cost in Anesthesia," the "Spot the Error" videotapes, and the APSF clipboards intended for 0. R. use. These clipboards have printed on them an abbreviated anesthesia machine checklist and a relief exchange protocol.

Also in the exhibits, a portion of the Ohmeda booth will be continuously showing the ASA Patient Safety Videotape Series.

Congress registration information is available by calling the ASA (312) 825-5586 or writing: 1'rS/WfSA;P.O.Box825;Deerfield,IL 60015.

There is also a pre-Congress meeting May 2 1 and 22 at the Grand Hyatt Hotel at Washington Center sponsored by the Yale University Department of Anesthesia. The meeting is entitled "Current concepts in non-invasive monitoring and patient safety." Registration information can be obtained by calling the Yale Office of Graduate and Continuing Education (203) 785-4578.

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Editorial: The Foundation Turns Two

In this issue, the first one of APSF's Newsletter Volume 3, it seems reasonable to reflect upon the first two years of the Foundation and its future The mission remains the same to encourage activities that will prevent patients from being harmed by anesthesia care. The Foundation has been enthusiastically received in many quarters. Some, however, have criticized us for being excessively oriented toward equipment monitors and state-of-the-art anesthesia machines. The Foundation's Executive Committee, indeed, encourages this criticism because it helps us to discover the directions we should be taking. Honest differences of opinions always exist among anesthesia clinicians.

Recently, I wrote the following to one of our supporters who had voiced concerns; "The APSF continues to have as its only goal the enhancement of safety in anesthesia. We have had to take this development one step at a time and are indeed still feeling our way. I believe that the first major approach was to try to cut the incidence of catastrophic events, especially those which have been undoubtedly reduced by use of oximetry and capnography. The Foundation has very strongly and studiously avoided anything approaching the setting of standards or demanding that certain equipment or machines be used. Rather, we have attempted to emphasize safety through education and awareness' " I believe, in fact, that the expenditure of Foundation funds so far has been primarily in areas not benefiting industry although industry has provided the major financial support thus far to the Foundation.

In my view, the two most important undertakings by the Foundation have been the Research Grant Program and the APSF Newsletter. Neither of these is equipment oriented. It is interesting to examine the front page lead headline in some of the newsletters published thus far: Leadership and Quality Care in Anesthetic Practice; FDA Issues Pre-use Check-out; Anesthesia Claims Decrease; ASA Adopts Basic Monitoring Standards; Support and Service Crucial to Safety; Better Labels Will Cut Drug Errors.

Efforts will continue to promote education in anesthesia patient safety as the prime focus of the Foundation. Hopefully, the attempts so far the research grants and newsletter noted above, the videotape and book on Capnography, the videotape and book on Safety and Cost Containment in Anesthesia, the videotape Spot the Error and the postponed Grand Anesthesia Safety Symposium will be seen as true educational undertakings.

This year the Foundation will bring together several investigators working on simulators and a number of anesthesia educators to explore the potential use of simulators in anesthesia education and training, especially in the management of the rare crisis situation. Strong efforts have been made to eliminate any commercialism in this workshop.

The Foundation is funding a survey to assess national and international work practices of anesthesiologists. A pilot study, already completed, is to be expanded into a larger survey, reviewing the role of fatigue and anesthesia patient safety.

Consideration of standards for anesthesia machines has been an agenda item for the ASA Committee on Patient Safety and Risk Management not the Anesthesia Patient Safety Foundation. The Foundation's Committee on Education and Training, however, is planning a multi-disciplinary conference to prepare a set of educational materials for describing current safety features of the anesthesia machine and whether or not older machines can be modified to include individual safety devices.

In the last issue, APSF circulated a questionnaire seeking opinion of the readers concerning future safety symposium presentations. We encourage participation by all of you who read the Newsletter in helping the Executive Committee and Board to plan programs over the next two years. Examine us, criticize us, write to us. Let us work together toward the complete elimination of preventable anesthesia morbidity and mortality.

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

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Monitoring Seen Cost-Effective in Injury Prevention

by Allen K. Ream, M.D.

Although recent publications have strongly advocated the use of monitors to reduce patient morbidity and mortality, there has been difficulty achieving agreement on the level of monitoring which is desirable, or which can be justified by economic constraints. A recent publication by Whitcher, et all addresses this issue, and proposes a method of analysis based on the cost of injuries, and the expected savings when monitoring is used. It was presumed that 50% of the cost associated with insurance premiums could be saved by using the recommended monitoring equipment.

The authors focused on preventable injuries. They drew a careful distinction between injuries which are preventable, and injuries which are due to an error in the legal sense; i.e. which fall below the standard of due care established by legal means.

The results of these financial calculations are dramatic. The savings of a 50% reduction in insurance costs are approximately $35,0001 operating room/year. The proposed monitoring standard costs approximately $7,000/operating room/year, for a net savings of $28,000/operating room/year.

The costs of injuries was estimated using data provided by the Saint Paul Fire and Marine Insurance Company, and referred publications. In each case, the claims were associated with the administration of anesthesia.

The review of published studies of injuries associated with anesthesia and the authors' experience suggest that it is conservatively possible, with adequate monitoring, to avoid 50% of patient injuries using current monitoring technology. The authors propose a monitoring standard which, in their opinion, could achieve this savings.

While it was not possible to eliminate all assumptions, it was possible to check most of the assumptions using several sources. In additions, the results of this study were presented as a scientific exhibit at two consecutive annual meetings of the American Society of Anesthesiologists (ASA). Discussants included many of the cited authors, and many representative physicians and manufacturers, as well as attorneys and representatives of the insurance industry. No serious differences of interpretation were encountered during this process.

Assumptions Critical

The critical assumption is that a 50% reduction in expense would be achieved. The authors agree that this assertion is difficult to prove. They note their own opinion, and that of the majority of authors reviewing injury associated with anesthesia, supports this view.

There was a presumption that savings in insurance costs would be passed through. It was argued that this is rational; the industry is competitive, the costs are high enough to ensure comparison shopping, and deductibles (particularly for the hospital) have risen high enough to ensure a significant degree of pass-through. Evidence of insurance company support for monitoring is cited.

Other aspects of the analysis appear conservative. The calculated costs per operating room were based on the assumption of the full-time practice of anesthesia; lower activity would increase the expense. Savings could occur not only by identifying events in time to prevent injury, but also in disproving claims or preventable events which did not occur. Further, where several sources gave similar but differing values, the value leading to the smaller saving was used.

The authors proposed the following monitoring equipment: automatic sphygmomanometer, pulse oximeter, capnograph, spirorneter, halometer, breathing circuit oxygen analyzer, stethoscope, ECG monitor, and thermometer. This led to an estimated acquisition cost of $22,500 (see Table) or approximately four times the estimated minimum cost of satisfying the ASA Standard for Basic Monitoring approved in October, 1986.

In an accompanying editorial by one of the reviewers, it was suggested that it is appropriate to spend up to the anticipated savings associated with improved monitoring, given only that each monitor added would further reduce the risk of injury. The editorial suggests an enhanced list of monitors, acquires a more elaborate capnograph and pulse oximeter, and additionally monitoring transcutaneous oxygen and carbon dioxide, the neuromuscular twitch response to stimulation, continuous noninvasive blood pressure, and continuous measurement of cardiac output. This further enhancement in monitoring support led to a fourfold increase in expense over that proposed by Whitcher, et al. However, the cost is still less that the suggested savings in insurance expense.

One of the difficulties in this form of analysis is the difficulty of designing a controlled study to evaluate the assumptions. It is generally agreed that monitoring is highly desirable and seems likely to reduce patient mortality/morbidity compared to the unmonitored state. The American and Canadian Societies of Anesthesiologists have recommended minimum standards. Thus, while the degree of safety afforded is difficult to measure, the failure to monitor appears to increase the risk of injury to the anesthetized patient. A controlled study to define the magnitude of this risk seems hard to justify for the patient control group.

Proposed minimum standard for patient monitoring equipment available during anesthesia

Equipment Cost

Pulse oximeter 5,500.00

Capnograph 4,600.00

Spirometer 1,000.00

Halorneter 3,5M.OO

Automatic sphygmomanometer 300.00

Breathing circuit oxygen analyzer 800.00

Stethoscope 50.0

Electrocardiogram 4,550.00

Thermometer 200.00

Total usual initial cost per room $22,500.00

If the appropriate study could be devised, it would also be of great value to identify the order in which different monitors should be added to the operating room to assure maximal reduction of risk, given an inadequate monitoring budget. It could be argued that the marginal utility (benefit) of adding one more monitor (e.g. the last on the recommended list) would not exceed its cost. Whitcher et. al. argued otherwise, suggesting that a minimally acceptable monitoring configuration should afford positive identification of all major pathways to patient injury. (See figure)

It is worth nothing that this analysis focused on only one form of cost insurance premiums and the associated deductibles. Injuries seem to carry a significant economic and social price in other measures as well, including the high incidence of physician suicide noted in one careful study, and the effect on hospital and physician operating practices in order to avoid claims.

While this analysis could not absolutely prove the authors' assertion of savings, the weight of evidence seems to favor this conclusion. How can one defend a failure to reduce operative morbidity and mortality if the reduction is cost effective? Thus, there is a strong incentive to either act on these conclusions, or to disprove them.

1. Whitcher C, Ream AK, Parsons D, Rubsamen D, Scott J, Champeau M, Sterman W, Siegel L: Anesthetic Mishaps and the Cost of Monitoring: A Proposed Standard for Monitoring Equipment. Clin Monit 4(l): 5-15, 1988 (January).

Dr. Ream, Department of Anesthesia, Stanford, is a Director of the APSE

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ASA and CDC Plan National Study of Anesthesia Outcome

by Fredrick K. Orkin, M.D.

How safe is anesthesia now? How can anesthesia care be made safer? Almost 25 million surgical operations are performed annually in U.S. acute care hospitals, yet remarkably little is known about the rates and causes of serious anesthesia-related complications. Thus, the American Society of Anesthesiologists and the federal Centers for Disease Control recently agreed to jointly support a pilot study during 1988 to help plan a national study of mortality and severe morbidity associated with anesthesia. The pilot study will not provide outcome data or test hypotheses but rather will test and improve the proposed methodology for the national study.

The national study seeks to learn how to improve the quality of anesthesia care. Data will be collected in a representative sample of hospitals and analyzed to estimate national and regional incidence rates of anesthesia-related mortality and severe morbidity. The focus will he factors having potential for preventive intervention: Anesthesia factors such as technique and patient monitoring; patient factors such as the presence of hypertension, obesity, and smoking; and hospital factors such as the type of anesthesia provider and volume surgery.

All mortality and severe morbidity occurring within 48 hours of an anesthetic will be studied in patients undergoing inpatient and outpatient surgery, cesarean section, and radiologic procedures. An in-hospital investigator will collect detailed information which will be reviewed in a blinded fashion by independent expert panels consisting of two anesthesiologists and one surgeon. These panels will assess the contribution of the anesthesia care to the adverse event. In addition, using other patients at the same hospitals who (lid not suffer complications, a case-control study will examine the anesthesia and personal factors that can affect the occurrence of anesthetic-related adverse events. The analysis will focus on anesthesia and patient variables, while controlling for such factors as type of surgical procedure and the patient's age and ASA physical status classification.

A pilot study is necessary to improve the protocol and, in particular, to determine the feasibility of different aspects of what is expected to be a three to five-year, multimillion-dollar study for which governmental, industrial, and other private funding would be sought. It is recognized that substantial scientific issues must be resolved and funding obtained before such a large effort can be launched. The pilot study will involve three months' data collection in five hospitals chosen so that there is representation of a hospital with a medical school affiliation, a community hospital with no medical school affiliation, and anesthesia provided by nurse anesthetists.

This joint effort re-suits from more than I 8 months' collaboration between Dr. Douglas N. Klaucke of the CDC's Division of Surveillance and Epidemiologic Studies and the ASA Task Force on Morbidity and Mortality, drawn from the Committee on Patient Safety and Risk Management, chaired by Dr. Ellison C. Pierce, Jr. Task Force members are Drs. Jeffrey B. Cooper, Stephanie M. Duberman, Fredrick K. Orkin, and Alan D. Sessler. For the pilot study, the ASA will provide administrative support and anesthesia consultation, the CDC will provide epidemiologic consultation, a blanket of confidentiality over data, and oversight of the project. Battelle Human Affairs Research Centers, a health care consulting firm, will collect the data as a subcontractor. This collaboration is already being described as a model for mutual cooperation between a medical society and a governmental agency. Further information was presented in the February issue of the ASA Newsletter and is available from Task Force members.

Dr. Orkin, University of California at San Francisco, is a Task Force member and co-e6tor of Complications in Anesthesiology.
 
 

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From the Literature: New Mortality Study

Editor's note: Suggestions are welcome for other pertinent articles from the anesthesia patient safety literature to be summarized in future issues.

Buck N, Devlin HB, Lunn JN: 7he &port of a Confidential Enquiry into Perioperative Deaths. London, Nuffield Provincial Hospitals Trust and The King's Fund for Hospitals, 1987.

This is an interesting, and awe-some, 163-page report (including 230 tables) of The Confidential Enquiry into Perioperative Deaths (CEPOD), which summarizes the perioperative deaths occurring during a 12-month period (I 1/85-10/86) in National Health Service hospitals in three regions of Britain. A collaborative effort of the Association of Anesthetists and the Association of Surgeons of Great Britain and Ireland, this undertaking sought to determine ways to improve the delivery of surgical (including anesthesia) cam As the most recent and one of the largest such study, it represents an important addition to the literature on anesthetic related adverse outcomes and risk management in our specialty.

The study design was rather simple-. voluntary, confidential reporting of all deaths occurring within 30 days of surgery. The involved anesthesiologist and surgeon completed separate, detailed questionnaires which were "rendered anonymous" later destroyed). Blinded information on each case was sent to consultants in surgery and anesthesia who evaluated the appropriateness of surgery, adequacy of monitoring, quality of rare, and avoidability of the death. The consultants were also asked for a judgment on the contribution of the surgical condition, co-existing disease, anesthesia, and/or surgery to the death.

The study directors set out to review 4034 deaths occurring among more than half a million surgical procedures. (This gross mortality rate, 0.7 percent, is less than expected.) However, they were able to obtain information from both the surgeon and anesthesiologist for only 2391 deaths (59.3%), suggesting that, even in a country with a much less litigious atmosphere, voluntarism has severe limitations.

Consultants differed widely in their judgments: Surgeons and anesthesiologists attributed only 0. I percent of the deaths solely to an error in anesthesia management, and each discipline acknowledged that some 20 percent of deaths were due to avoidable factors in its sphere of activity. Interestingly, anesthesiologists felt that anesthesia and surgery each contributed to 14 percent of deaths, whereas surgeons accepted blame for 30 percent, leaving only 2 percent to anesthesia.

The most interesting, and sobering, results relate to more global aspects of the surgical experience: As expected, 79 percent of the deaths occurred in those over 65 years, whereas the elderly comprised only 2 percent of the surgical population of these hospitals. Consultants felt that the surgical disease caused a third of deaths and contributed to two thirds; similarly, co-existing disease accounted for about one fifth of deaths and contributed to one half. Overall, there was a strong suggestion that much surgery had been undertaken inappropriately in moribund or terminally ill patients who would not have benefited. The study also documented highly variable supervision of surgical and anesthesia house staff, as well as disturbingly high correlations of off-hours, unsupervised activity with sicker patients and higher mortality. Using their own classification of urgency of the surgery, the investigators also showed that few operations must be performed at night.

Although many of their conclusions relate specifically to the organization of surgical care delivery under the National Health Service, there is much in this report that is of broad generic applicability to the conduct of quality assurance and risk management programs. The report may be obtained from the Nuffield Provincial Hospitals Trust (3 Prince Albert Road, London NW I 7SP, England). A summary prepared by Drs. Lunn and Devlin, as well as an editorial, appeared in 7he Lancet (2:1384-1386 and 1369-1371, respectively, 1987).

Abstracted by Fredrick K. Orkin, M.D., Department of Anesthesia, University of California, San Francisco, School of Medicine.
 

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Letter to the Editor: Wandering Anesthetists

To the Editor:

Regarding the September editorial about anesthetists leaving the O.R., the point struck home. I am one of 12 staff of a fully accredited associate teaching hospital of the University of Calgary Medical School. Early in 1987, some of the O.R. nurses got annoyed. They complained that some of us were wandering about a little too much. They complained directly to the hospital Patient Care Committee, sidestepping all normal channels. This was very effective. Any anesthetist may be unaware of how "wandering" can become a habit.

No hospital should be accredited if it has no monitors and has otherwise inadequate equipment or if there is failure to use the monitors or reasonably standard machines. Hospital administrations and boards must be rapidly brought to a state of mind that requires all the appropriate "goodies" and their use.

Our own battles are somewhat different. With anesthesia machines getting more and more complex and expensive, it means a huge replacement cost once a decade or sooner. Our next bill will come to half a million dollars just for machines and, in addition, the whole hospital (O.R., Recovery, I.C.U.) is going to have oximeters.

Arthur P. Melgrave, FRCP(C), Calgary General Hospital, Calgary, Alberta, Canada
 

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Additional ASA Patient Safety Videotapes Completed

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

Videotapes # 1 0 and #II in the ASA Patient Safety series were taped in December and January. John 1. Savarese, M.D. was the producer of "Safety in Neuromuscular Blockade," which was prepared by Park Row at the Massachusetts General Hospital and funded by Burroughs-Wellcome. Bernard V. Wetchler, M.D. was producer of "Safety in the Post Anesthesia Care Unit". The videotape was funded by ASA and an educational grant from Datascope. It was prepared by the FDA at the University of Florida, Gainesville.

For Anesthesia Departments in United States hospitals of more than I 00 beds, the entire series is available free through the Burroughs-Wellcome Company. Interested departments that have not already been placed on the mailing list may do so by contacting the local Burroughs-Wellcome representative.

The series will be available for purchase by Anesthesia Departments outside the United States at the Anesthesia Patient Safety Foundation Booth during the Ninth World Congress Meeting in

Washington D.C., May 22-28, 1988.

The series is available on four Cassettes as follows:

Cassette A. ASA Overview, Preventing Disconnection in the Breathing Circuit, Anesthesia Machine Check-out.

Cassette B. Adverse Events, Anesthesia Record Keeping, Human Error.

Cassette C. Monitoring with the Six Senses, Monitoring with Instruments, Anesthesia Equipment Service. An Organized and Cooperative Approach to Maintenance and Repair

Cassette D. Patient Safety in Neuromuscular Blockade, Patient Safety in the Post Anesthesia Care Unit.

It should be noted that at least one malpractice insurance company in the United States has allowed a reduction in anesthesia malpractice premiums for anesthesiologists who view the videotapes annually.

Dr. Pierce is President, APSE

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From the Literature: Death During Spinal

Editor's note: Suggestions are welcome for other pertinent articles from the anesthesia patient safety literature to be summarized in future issues.

Caplan R.A., Ward RJ, Posher K., Cheney F.W.: Unexpected cardiac arrest during spinal anesthesia: a dosed claims analysis of predisposing factors. Anesthesiology 68: 5-1 1, 1988.

The authors of this interesting paper reviewed some 900 cases compiled by the American Society of Anesthesiologists Committee on Professional Liability during its nationwide study of closed insurance claims from major anesthetic mishaps. The authors describe 14 cases of intraoperative cardiac arrests during spinal anesthesia in otherwise healthy patients. They maintain that each mishap occurred for less than obvious reasons, and may represent a "sentinel event: an unusual or unexpected outcome that should not occur under the prevailing conditions of health care." These cases thus provided an opportunity for a detailed analysis that might "reveal recurring patterns of clinical management that contributed either to occurrence or outcome".

Citing the "almost irresistible tendency to assume that overt negligence has played an important contributory role [in an anesthetic catastrophe]", the authors were struck by "the overall adequacy of basic anesthetic care" in these cases. The patients were selected for spinal by experienced clinicians, the amount of supplemental sedation did not appear to be excessive, and intraoperative vigilance appeared to be adequate. The highest spinal level was T4' The average time between the last verification of adequate circulation and ventilation and the first indication of problems was only 1.6 minutes. The average time between the first indication of inadequate circulation or ventilation and the onset of cardiopulmonary resuscitation was also only 1.6 minutes. In spite of prompt resuscitation efforts, six patients died in the hospital and another seven suffered severe neurologic dysfunction.

The authors were able to identify two management patterns which correlated with these poor outcomes. The first was the use of "sufficient sedation to produce a comfortable appearing, sleep like state in which there was no spontaneous verbalization". This occurred in seven of the patients, and in six of these cyanosis was noted prior to the cardiac arrest. Thus, the possibility of respiratory insufficiency as the precipitant of cardiac arrest was raised for in approximately half of the patients.

A second pattern involved the conduct of CPR. The average duration of CPR was eight to ten minutes; ephedrine and atropine were given early during the resuscitations, but epinephrine was not given until about five minutes after the initiation of CPR, and, on the average, about seven and one half minutes after the first clue of hemodynamic compromise. The authors suggest that the presence of high spinal anesthesia with concomitant sympathectomy, and hence relative intravascular hypovolemia and bradycardia, may have explained the difficulty of successfully resuscitating these patients after the onset of cardiac arrest.

In concluding, the authors reiterate that these cases represent cardiac arrests which "seemed to evolve with unexpected speed against the background of apparently stable hemodynamics." They point out that they cannot fully understand this based on the data, nor can they determine the incidence of such occurrences, but "wish to emphasize that spinal anesthesia-conducted under routine conditions and in a standard manner-carries a poorly understood potential for sudden cardiac arrest and severe brain injury in healthy patients".

They offer three suggestions for anesthetic care based on their findings: First, the use of a pulse oximeter for sedated patients; second, the use of epinephrine "early in the treatment of sudden bradycardia"; and third, "a full resuscitation dose of epinephrine. . immediately upon the recognition of cardiac arrest".

Dr. Arthur Keats, in an accompanying editorial, praises the efforts of the University of Washington team and enlarges the discussion of possible mechanisms for cardiac arrest and inadequate resuscitation of these patients. Caplan and his coworkers have clearly provided a valuable lesson in analysis of this uncommon type of anesthetic mishap.

Abstracted by Kimball C. Atwood, M.D., Harvard Medical School and New England Deaconess Hospital, Boston.

Simulators Studied for Role in Patient Safety

by J.S. Gravenstein, M.D.

The APSF is currently examining what clinical I anesthesia simulators could contribute to the training and education of anesthesiologists and nurse anesthetists.

A number of investigators have developed simulators that can be used to demonstrate the pharmacokinetics of drugs, the responses of patients to anesthesia, the workings of an anesthesia machine, and the meanings of variables reported by monitors, to name a few.

These simulators allow the trainee to "play a scenario" without threatening the safety of the patient and to explore what would happen if an adverse process were allowed to go unchecked. Of course, simulators are widely and successfully used in many other are-as. Best known are the flight simulators employed by all major airlines and the Air Force. These simulators are wonders of technology. Even though they are enormously expensive, (one flight simulator may cost $ 1 0,000,000), the aviation industry has found them to be cost effective. Other users of simulators (including the Navy and the atomic energy industry) concur.

The Foundation raised the question: What can simulators do for us in anesthesia? Will they be simply research toys for a few computer wizards or can they really play an important part in the training and education of clinical personnel?

In September of 1988, the Foundation will bring together a group of educators in anesthesia and the designers of several simulators to answer that question. The educators will have an opportunity to examine and test the simulators (or be tested by them) and explore how these devices might fit into the educational curriculum of trainees as well as programs for continuing education. Once we understand the role simulators might play in our specialty, we can ask the question whether these newcomers to medicine will be cost-effective.

Dr. Gavenstein, University of Florida, Gainesville, is a member of the APSF Executive Committee.

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Letters to the Editor

To the Editor:

The current ASA standards for temperature monitoring state that "When changes in body temperature are intended, anticipated, or suspected the temperature shall be measured. " I have recently been apprised of a caw of Malignant Hyperthermia that was noted late in the course of the syndrome. By the time suspicion of MH had be-en raised and temperature monitoring was secured, the rectal temperature was well over 102 ' F. Other metabolic changes ensued which eventually lead to the demise of the patient.

I have also been involved in consultations on several legal cases involving Malignant Hyperthermia. In at least one of them, a verdict was rendered against the defendant anesthesiologist in large part because the anesthesiologist failed to continuously monitor the patient's temperature. Reasons commonly given for not continuously monitoring temperature include lack of availability of equipment, inconvenience of placing temperature probes, and possible patient injury from temperature probe placement. All of these excuses are invalid. Temperature monitoring devices are relatively inexpensive. Probes can be placed in the axilla, in the pharynx or in the esophagus and indicate, at the least, temperature trending.

Another reason for failing to monitor temperature, is that fever is said to be a late sign of Malignant Hyperthermia. Although true in general, in specific cases, temperature elevations may occur early in the course of MH.

Furthermore, temperature monitoring detects hypothermia which may result in patient morbidity, especially in children.

I therefore believe that the Anesthesia Patient Safety Foundation should urge the American Society of Anesthesiologists to change the standards of intraoperative monitoring to include continuous body temperature monitoring for all patients receiving general anesthesia. I contend that body temperature changes can be anticipated in any surgical patient undergoing general anesthesia and should be measured. Medico-legal considerations and quality care demand nothing less.

Henry Rosenberg, M.D., Professor and Chairman, Department of Anesthesiology, Hahneman University. Chairman, Professional Advisory Council of MHAUS.
 

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APSF Membership Procedure for ASA Members

Many ASA members have expressed some confusion as to how they can apply for or renew membership in the Anesthesia Patient Safety Foundation (APSF) in light of the statement approved by the ASA House of Delegates encouraging ASA members to become dues paying members of APSF.

There is a simple procedure for ASA members to apply/renew their membership donation to the APSF. The Annual ASA Dues Statement contains a section which enables an ASA member to check-off his/her annual membership donation to Patient Safety and include it with the ASA dues payment. This method insures continuation of your existing APSF membership or establishes a new membership in your name if you have not joined previously.

The ASA dues statement shows Patient Safety with a pre-printed $2 5. 00 contribution amount. While we would like every ASA member to be at least a $25.00 member of APSF, we have found many ASA members have supported APSF with a larger donation, such as those Groups organized as Professional Corporations (P.C.), which contribute the Corporate Member donation of $500.00. To encourage this level of support,

ASA members wanting to make a larger donation need only to cross-out the pre-printed $25.00 contribution and enter next to it the amount of their donation.

Through the dues check-off mechanism, ASA members can assure their membership and annual support of APSF. However, if you have already paid your 1988 ASA dues but did not check off a contribution to APSF, you can still support the Foundation by filling out an APSF member application and returning it with your member donation. Copies of the application can be obtained by calling the APSF office at (312) 825-5586.
 

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Major Evaluation of Equipment Published

"Anesthesia Systems" is the title of the January, 1988 issue (Vol. 17, No. 1) of Health Devices published by ECRI in Pennsylvania. This extensive evaluation of anesthesia machines, including the newest Drager and Ohmeda models, and related equipment contains brand name and model specific ratings and listings of advantages and disadvantages of the various systems. Further, there are detailed suggestions on how to choose an anesthesia system to meet individual needs.

Under the heading "Evaluation: anesthesia systems" are included sections on the Penion AM 1,000, new models and changes, and on automated record keeping in anesthesia.

Health Devices is a hospital-oriented publication available by subscription. Single copies such as this issue on anesthesia systems are $50.00. For more information, contact ECRI, 5200 Butler Pike, Plymouth Meeting, PA 19462, (215) 835-6000.
 

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Notes

The Anesthesia Patient Safety Foundation Newsletter is the official publication of the nonprofit Anesthesia Patient Safety Foundation and is published quarterly in March, June, September, and December at Overland Park, Kansas. Annual membership: Individual $25.00, Corporate $500.00. This and any additional contributions to the Foundation are tax deductible @Copyright, Anesthesia Patient Safety Foundation, 1988.

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

APSF Executive Committee:

Ellison C. Pierce, Jr., M.D., President; W Dekle Rountree, Jr., Vice-President; E.S. Siker, M.D., Secretary; Burton A. Dole, Jr., Treasurer; Jeffrey B. Cooper, Ph.D.; Joachim S. Gavenstein, M.D.; James F. Holzer, J.D.

Newsletter Editorial Board:

John H. Eichhorn, M.D., Stanley 1. Aukburg, M.D., Jeffrey M. Beutler, C.R.N.A., M.S., Ralph A. Epstein, M.D., David E. Lees, M.D., Bernard V. Wetchler, M.D., Mr. Mark D. Wood

Address all general, membership, and subscription correspondence to:

Administrator

Anesthesia Patient Safety Foundation

515 Busse Highway

Park Ridge, IL 60068

Address Newsletter editorial comments, questions, letters, and suggestions to:

John H. Eichhorn, M.D.

Editor, APSF Newsletter

Dept. Anesthesia

Beth Israel Hospital, DA-717

Boston, MA 02215