ANESTHESIA PATIENT SAFETY FOUNDATION
NEWSLETTER

Volume 1, No. 4, pp 21-32
December, 1986
Table of Contents

Anesthesia Claims Decrease
APSF Awards First Research Grants
From the Literature
Letters to the Editor
Monitoring Policies Adopted by Hospitals
Safety Technology Shown at ASA
Risk Modification in Anesthesiology
Vienna M&M Meeting Studies Safety
Current Questions in Patient Safety
Foreign Correspondence:
Notes




Anesthesia Claims Decrease

Number Rises More Slowly But Severity Remains High

by Mark D. Wood

In the past, anesthesiologists were viewed as a high-risk group by professional liability insurers. The risks of using anesthesia and the frequency and catastrophic nature of anesthesia claims contributed to this view.

However, during the past several years, the loss experience of anesthesiologists has improved. Claim frequency has increased for all physicians, but relative to other specialties, claims reported by anesthesiologists have increased more slowly, according to the St. Paul Fire and Marine Insurance Co.

Between 1979 and 1985, claims reported by all physicians increased in frequency by 76.3 percent. During the same time period, claims reported by anesthesiologists increased 32.6 percent.

In 1979, the frequency of claims reports by anesthesiologists was 39 percent higher than the average for all physicians. By 1985 the same figure decreased to 4.7 percent above the average claim frequency for all physicians.

Because of this improvement, St. Paul Insurance reduced the rate relativity of anesthesiologists from 5.0 to 4.0, effective July 1, 1985. Anesthesiologists now pay less for their professional liability coverage than they would with a 5.0 relativity factor.

At the same time, St. Paul created a new rating classification, Class 5a, for anesthesiologists alone. The new class retains the lower relativity factor based on improved claim experience. Previously, anesthesiologists were groups with otorhinolaryngological, general and plastic surgeons, among others (see box on page 23).

Lower frequency of claims for anesthesiologists is due to many factors. Anesthesiologists' longstanding concern for patient safety, improvement of anesthetic technique, and utilization of new medical technology all appear to have helped reduce frequency of claims.

Progress has also come from the concern of anesthesiologists, nurse anesthetists, and others interested in studying anesthesia claims. Their efforts help determine where accidents occur and what can be done to avoid them.

In addition, monitoring standards passed by the American Society of Anesthesiologists establish and endorse high-quality patient care through basic intraoperative monitoring. Providers who practice in accordance with these standards and take advantage of technological advances will further help reduce claims.

Although frequency of anesthesia-related claims has been reduced, severity of claims remains high relative to that of most other physicians. As shown in the accompanying table, when losses do occur, many continue to be catastrophic in nature.

Recent closed-claim studies show that a large

number of anesthesia-related claims involve unrecognized perioperative hypoxia. By using monitoring equipment such as the end4idal C02 monitor for ventilation and the pulse oximeter for oxygenation anesthesia providers can identify the soon-to-be or actually hypoxic patient before any injury and thus make a positive impact on catastrophic claims by reducing hypoxia-related injuries.

Anesthesiologists have reduced the over-all frequency of anesthesia-related claims. With continued effort and concern for patient safety, anesthesiologists can also impact the frequency of catastrophic claims and further improve their professional liability rates.

Mr. Wood is Medical Services Manager, Risk Management, St. Paul Insurance, and a member of the Newsletter Editorial Board

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APSF Awards First Research Grants

by Arthur S. Keats, M.D.

The Anesthesia Patient Safety Foundation announced the first awards of its Research Grants Program begun in 1986. The purpose of the program is to support clinical research directed toward enhancing patient safety during anesthesia. Twenty-six applications were received and all available grant funds were awarded to four grants whose applications were ranked highest by the Committee on Scientific Evaluation. The grants are:

1. David M. Gaba, M.D@Stanford University School of Medicine-Evaluation of Anesthesiologist Problem Solving Using Realistic Simulations

2. Marsha M. Cohen, M.D.-University of Manitoba-Defining Outcomes Associated With Anesthesia

3. Dwayne R. Westenshow, Ph.D.-University of Utah School of Medicine-A safer Anesthesia Machine Through Model-Based Alarms

4. 1. lance Lichtor, M.D@University of Chicago, Pritzker School of Medicine-The Risk of Surgery and Anesthesia: A Retrospective Analysis

Dr. Gaba will use a mannequin simulator in an operating room environment to mimic life threatening situations which may occur during anesthesia. He will then observe and record the decision making process of several groups of anesthesiologists as they diagnose and treat the simulated situation. The study promises to identify elements of problem solving which distinguish experienced from novice anesthesiologists and may be able to quantify the effects of modifiers such as fatigue on problem solving ability.

Based on experiences with one institution's system for surveillance of anesthetic morbidity and mortality, Dr. Cohen will attempt to refine the system now in place by reducing subjectivity, improving data collections, and defining outcomes. The major objective is to develop a system simple and cost effective enough to be applicable for quality assurance purposes within hospitals and for multiinstitutional studies of anesthesia outcomes.

Dr. Westenshow will study the problems created by multiple monitors and alarms which act independently in terms of sensitivity and alarm limits. By computer modeling and simulation, states of operation of multiple sensors which may complicate patient care wig be identified. By assigning alarm priorities, a schematic display of alarms will be developed to identify clinical problems correctly and convey appropriate priorities,

Dr. Lichtor will examine data collected since 1964 by the National Center for Health Statistics as a possible source of information on incidence of death related to anesthesia in the United States. These data are coded under a variety of diagnostic codes which need to be explored for their applicability to anesthetic related mortality.

The Anesthesia Patient Safety Foundation awards grants annually on the basis of competing applications. An announcement of the 1987 Grant Program appears elsewhere in this issue

Dr. Keats is Chief, Division of Cardiovascular Anesthesia, Toms Heart Institute, and Chairman, APSF Committee on Scientific Evaluation.
 

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From the Literature

Editor's note: In each APSFNewsletter, a pertinent publication from the anesthesia patient safety literature YAII be summa6zed. suggestions for future issues are welcome.

Lunn, J.N. (ed): Epidemiology in Anesthesia. London, Baltimore and Victoria: Edward Arnold lid, 1986. Edward Arnold, 3 East Read Street, Baltimore, MD 21202; $34.50.

John Lunn, M.D. of Cardiff, has studied and written extensively about anesthesia morbidity and mortality in the UK for many years. As editor of this new book, he has collected ten chapters by thirteen international specialists applying principles of epidemiology to evaluation of anesthetic practice, including outcome, complications, occupational hazards, and developing standards. A goal of the book is to have the data used toward directing of effective planning and improving of clinical anesthesia. Some of the subjects have been examined at a scientific meeting held by the Faculty of Anaesthetists of the Royal College of Surgeons of England in 1983.

Highlights of the publication include the description of principles of epidemiology by S.C. Farrow of the University of Wales and EG.R. Fowkes of Usher Institute, Edinburgh; risk in anesthesia by H.H. Bendixen and S.M. Duberman of Columbia University; evaluation of the halothane controversy by A.A. Spence, Royal Infirmary, Edinburgh; chapters on the anesthetic record and documentation by Lunn himself and R.G.F.L. Seed, Riyadh Armed Forces Hospital; and discussions of pollution in the O.R. and development of new anesthetic drugs. In the last chapter, J.A. Bushman and J. Cushman of the Research Department of Anaesthetics at the Royal College of Surgeons look to the future in examining use of computers in anesthetic records.

AU of the chapters are good (some outstanding)

descriptions of the important areas of anesthesia epidemiology. This is all fitting, with the recent worldwide explosive interest in anesthetic patient safety, risk management, and quality assurance The book is recommended for all practicing anesthetists interested in lowering morbidity and mortality in anesthesia practices as every single one of us should well be.

Chapman-Clibum, G. (ed): Risk Management and Quality Assurance: Issues and Interactions, Special Publication. Quality Review Bulletin. Joint Commission on Accreditation of Hospitals, 875 North Michigan Avenue, Chicago, Illinois, 60611. 1986; $30.00

Katz, R.L. (ed): Safety in Anesthesia. Seminars in Anesthesia, Vol. 5, No. 3, September, 1986. Grune & Stratton, Inc., 6277 Sea Harbor Drive, Orlando, Florida 32821; $19.50.

These two additional publications should be of considerable interest to anesthetists working toward improved patient safety as the two approach the problem from different view points. Between them, they add considerably to available information for use in the United States.

Overseas readers should be aware that the Joint Commission on Accreditation of Hospitals (ICAH) is the formal accrediting body for hospitals in the United States and has recently undertaken a strong program towards risk management as well as measurement of outcome of patient care in the hospital, with the obvious objec6ve of improvement.

Contents of these publications are complimentary.

The first contains chapters on risk management in a number of areas, including anesthesia (reprinted in this Newsletter). In addition, the volume examines the professional liability crisis in the United States, the epidemiological structure of risk management, medical management analysis, relating quality assurance to credentials and privileges, and importantly, an integrated quality control program for anesthesia equipment.

The volume on Safety in Anesthesia stresses patient monitoring and specifically examines anesthesia disasters, oxygen monitoring and oximetry, capnometry and capnography, mass spectrometry, agent monitoring, future techniques in monitoring, and standards of care from a legal viewpoint.

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

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Letters to the Editor

Quality of Machine Service Questioned

To the Editor:

Thank you for the APSF Newsletter which describes the Anesthesia Apparatus Checkout Recommendations that we routinely follow. I am concerned about the "valid inspection sticker". I believe it is generally thought that this implies service by a trained representative of the anesthesia machine supplier and that, according to a rather costly contract, this factory trained workman tears down the machines at least once a year, replaces rubber and worn parts, and replaces all vaporizers with factory cleaned and calibrated ones. Between his visits, a "trained" member of the biomedical engineering (BME) department makes emergency repairs. This is in the best of worlds.

Practically, there can be a different scenario: The maintenance and repair contract with the anesthesia machine company is not made, for reasons of economy. Instead, members of the BME department are trained for a week at a school conducted by one of the anesthesia machine companies. They are then deemed competent to do all routine maintenance and make emergency repairs on a variety of anesthesia machines. The result of such an arrangement is that, even after the anesthetist's careful check out as recommended, disastrous break-downs and malfunctions occur.

In my view, the greatest service that can be made by the APSF is to provide standards for anesthesia equipment maintenance and repair personnel, so that a "valid inspection sticker" would indicate a machine that should be safe

Elsie E Meyers, M.D. St. Louis, MO
 

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Monitoring Policies Adopted by Hospitals

Useful in Getting Equipment

by Ralph A. Epstein, M.D.

In November, 1985, the chiefs of anesthesiology of the 13 hospitals of the Capital Area Health Consortium in northern Connecticut agreed that there should be a uniform policy for oxygenation and C02 (ventilation) monitoring. The 13 hospitals in the group vary in size from less than 100 to more than 800 beds, including one small university hospital.

At the time of the meetings, some of the hospitals were just beginning to contemplate introduction of such non-invasive monitoring while others already had it in place for at least some of their patients. Despite this heterogeneity, it was unanimously voted "to adopt a standard of monitoring care for anesthesia patients to include the following:

0 Pulse Oximetry be available to every patient receiving any general or regional anesthetic.

9 Capno8raphy be available to every patient receiving general anesthesia.

o Pulse Oximetry be available to every patient recovering in a post-anesthetic recovery area.

e Capnography be available to every patient being mechanically ventilated in a post-anesthetic recovery area."

The minutes of these meetings are routinely distributed to the chief executive officers of all the member hospitals. There is now a consensus among the anesthesiology chiefs that the action one year ago has significantly increased their ability to convince their respective hospitals of the importance of such equipment for patient safety in anesthesia.

Dr. Epstein is Professor and Chairman, Department of Anesthesiology, University of Connecticut and a member of the ]Newsletter Editorial Board.
 

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Safety Technology Shown at ASA

by Charles E. Whitcher, M.D.

Many devices shown by technical exhibitors at the October, 1986 ASA Annual Meeting can enhance patient safety. A partial list is presented here

An impressive array of pulse oximeters was shown, probably reflecting increased demand and a perceived relationship to a standard of cam This is no surprise, since oximeters address a fundamental point, oxygen availability to tissues, and are considered sufficiently reliable and practical for routine use Prospective purchasers wig find significant differences among the many brands shown differences which have not been dearly evaluated in the peer-reviewed literature As with any such purchase, considerations should include the available documentation, as well as anticipated ease of servicing. Probe design is a critical feature which merits careful thought, including ease of application, secureness during use, and ease of removal at the end of the case. Most oximeters retain undesired features such as susceptibility to artifacts due to motion and electrocautery interference.

Standard of Care

Many capnometers were shown, some offering improved me of use and ease of calibration. This is another monitor approaching standard of care status. The capability of multi-system assessment (metabolic, cardiovascular, and respiratory), and a one-breath assessment of endotracheal intubation, are important patient safety features. Esophageal intubation can be reliably and rapidly detected. A useful, if not indispensable, feature to he considered is the C02 wave form display-to verify important features of the capnogram, return to zero and alveolar plateaus for each breath. This feature is provided built-in to certain capnographs, and as an accessory for others.

A new generation of multi-gas monitors was displayed by several manufacturers. The primary analyses Of C02, N20, and anesthetic halocarbons were most frequently based on the infrared absorption principle. Response is rapid, breath-by-breath. End-tidal N20 analysis may be useful in verifying the effects attributable to this agent. End-tidal halocarbon values are useful in assessing anesthetic depth. Inhaled concentration only, measured by certain analyzers, does protect patient safety. Infrared analyzers do not usually differentiate among anesthetic halocarbons; the agent being used must be manually entered. Thus, this method would not readily recognize unexpected mixtures or substitutions of agents.

Several of the new multigas analyzers were capable of in-circuit 02 analysis, using conventional polarographic or fuel cell technologies (with

anticipated needs of frequent calibration and maintenance). An alternative is an updated version of the paramagnetic 02 analyzer. Reported advantages are: breath-by-breath -response, high -liability, raggedness and minimal need for maintenance and calibration.

Other multigas monitors are capable of the rapid analysis of A gases of interest based on mass spectrometry or Raman photospectrometry. Selected units are capable of the specific recognition of halocarbons in mixtures. N2 is also readily measured and this is useful in the recognition of air embolism and the inward leakage of room air into the deadspace of face masks or patient sampling lines. Lack of N2 measurement may lead to the misinterpretation of gas analyses. Direct N2 measurement offers the most protection, but the summing Of 02, N20, C02, and halocarbon would estimate N2. This feature has not yet been offered among infrared analyzers.

An advance shown in central, time-shared mass spectrometer systems was the integrated display of gas analyses with other physiologic monitors e-S., oximeters and automatic sphygmomanometers. In one case, a relatively low cost, quantitative, real time, integrated capnograph with wave form display was shown. This equipment functions continuously in each room during the time the central system is examining other rooms, and even in case of system shutdown. This feature may substantially reduce the objection to central, time-shared systems.

New Type of Mass Spec

Mass spectrometers designed for stand alone use were shown. They are more compact and less expensive than units designed for time-sharing systems, although the per room cost would depend on the size of the suite. An obvious advantage is the near-re-al-time analysis and data display. Like the mass spectrometer, the Raman photospectrometer, a compact gas analyzer designed for stand alone use, directly measures ad respiratory gases on a breath-by-breath basis. This unit is claimed to be nearly ready for marketing.

Automatic noninvasive sphygmomanometers with appropriate alarms are considered by many anesthesia practitioners to contribute materially to patient safety. Regular, frequent measurements are obtained, regardless of the anesthetist's activities. The available units appear to function in a broadening range of patient age groups and conditions. Updating may be adjusted to short intervals, but measurements remain intermittent.

A potentially significant advance in sphygmomanometry was shown in an automatic, noninvasive, finger-cuff sphygmomanometer based on the Penaz principle. There is an arterial waveform and pressure readings are displayed on a beat-bybeat basis.

Noninvasive cardiac output monitors based on Doppler shift or transthoracic impedance plethysmography were shown. These could be promising monitors in selected cases.

Several different electronic stethoscopes were displayed. They are capable of amplifying distant heard sounds and breath sounds, and of selectively altering relative volumes. Note, however, that they retain the deficiencies of conventional stethoscopes: the total dependence on the attention of the anesthetist, and the absence of alarms.

Automated Records

Several computer implemented, automated record keepers were presented. These devices are indirectly related to patient safety. Vital signs from attached monitors are automatically recorded at frequent intervals regardless of activities of the anesthesiologist, without bias. Other data are precisely timed when manually entered. intraoperative and postoperative care review is facilitated; the effectiveness of treatment is apparent. Selected problems of these devices are the cumbersomeness of data entry and the possibility of the recording of artifacts. Acceptance of the concept among anesthesia practitioners remains to be seen.

Significant development in anesthesia machines include built-in, integrated patient monitoring systems. One manufacturer combined built-in monitors with an integral central alarm system. These improvements may contribute to patient safety by reducing confusion otherwise imposed by multiple monitors and alarms.

At least three sophisticated, new-generation ventilators were shown, intended primarily for use in the intensive care unit. In the realm of the operating room, recently, only minor ventilator improvements have been offered.

Other monitors and equipment shown at the meeting could merit mention in the context of patient safety, but the above illustrate the potential major role of advances in instrumentation in the effort to reduce preventable anesthesia morbidity and mortality.

Dr. Whitcher is Professor of Anesthesia (Clinical), Stanford University School of Medicine.
 

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Risk Modification in Anesthesiology

Ellison C. Pierce, Jr., MD

Ellison C. Pierce, Jr., MD, is Chairman of the Department of Anesthesia, New England Deaconess Hospital, Boston, and Associates Professor at Harvard Medical School

The first reported death from Anesthesia was that of a 15-yearold British girl given chloroform for toenail removal in 1848, only 15 months after William Morton first demonstrated the use of ether in Boston. Dr. John Snow, the first true anesthesiologist, maintained that the girl's death was caused by the direct action of chloroform on her heart. 1

Controversy concerning the relative safety of chloroform versus ether lasted some 60 years until it was shown that the combination of light not deep chloroform and its associated increase in circulating epinephrine could produce ventricular fibrillation. Nevertheless, chloroform continued to be used until the middle of this century. Dr. Snow also described the need to measure pulse and respiration rates to determine both depth of anesthesia and onset of circulatory failure, but even today the extent to which a patient undergoing anesthesia should be monitored is still debated.

In the United States, anesthesia is administered some 20 million times each year. The incidence of directly related mortality is believed to lie in the range of 1 per 10,000 to 1 per 4,000 administrations-some 2,0005,000 deaths each year. 2 Most writers suggest that most of these deaths are preventable and that they frequently involve human error. Keenan and Boyan, in a recent review, found the incidence of cardiac arrest due to anesthesia to be 1.7 per 10,000 administrations in their hospital, with a resultant mortality rate of 0.9 per I 0,000. In their study, they were able to identify a specific anesthetic error in 75% of the occurrences.

In other reviews, ECRI (Emergency Care Research Institute, a nonprofit biomedical engineering research association) and Pierce have outlined multifaceted approaches that must be taken if the incidence of avoidable anesthetic mishaps is to be reduced. 4,1 Duberman and Bendixen have emphasized that today the public expects near-zero rates of morbidity and mortality in generally healthy patients undergoing anesthesia. 6

Seriousness of the Problem

Although anesthetic medical liability claims make up only about 3% or 4% of the total in medicine, the indemnity paid exceeds 10%, a fact obviously related to the severity of the injuries. In reviews of closed and open anesthesia-related claim abstracts, certain types of problems clearly recur. 7,8 Variations in classification make comparisons difficult, but common complications include inadequate ventilation, difficult endotracheal intubation, esophageal intubation, inadvertent extubation, ventilator disconnects, relative or absolute overdosages, and bronchospasm.

In addition to the unknown number of anesthetic deaths each year, there are other anesthesia related mishaps -perhaps as many as

those leading to death-that result in severe morbidity such as permanent brain damage.

Eliminating anesthesia mishaps is as important as changing tort law to control the cost of medical liability insurance. Proper monitoring is a major nonlegal approach to this problem because backing up observation and vigilance with certain monitoring systems will reduce the number of mishaps. 6 For an anesthesiologist to ignore the need for such a backup system is folly Hypoxic accidents, for example, still occur, resulting in multimillion-dollar awards against hospitals and anesthesiologists as well as untold suffering for patients and their families.

It is of utmost importance, however, for all parties-the public, attorneys, insurance companies, the government, and physicians-to recognize that by no means are all adverse events during anesthesia a result of human error and therefore preventable. Rather, as Keats has stated, an unknown number are due to patient disease, idiosyncrasy, or other factors: anesthetists must not be unfairly blamed for these. 9 Tinker and Roberts agree:

The idea that if a patient dies or sustains injury, error must have played a causal role has spawned much legal profit Juries are led to believe, and indeed often want to believe, that any untoward outcome must be rooted in physician fault. Although this misbelief is exploited by lawyers, it is rooted in long-standing self-deprecatory thinking within anesthesiology in particular, but also by medicine in general.

Moreover, the extensive attention that the anesthesia community pays to the review of anesthesia mishaps probably contributes to the increased number-of suits filed.

Lastly, it is appropriate to stress that as anesthetic techniques continue to improve, sicker and sicker patients are successfully undergoing increasingly difficult and complicated surgery, such as open heart procedures and organ transplants. Authorities here and abroad agree that anesthesia morbidity and mortality have declined significantly in recent years.

Major Impediments to Change

The following are some of the problems preventing further effective reduction of avoidable anesthesia mishaps.

In the United States-in contrast with Great Britain and Australia, for example-satisfactory reporting systems, mandatory or otherwise, do not exist. Current data, meager at best, comes largely from analysis of insurance claim files and critical incident studies. 7,8,11

The difference in practice patterns among anesthesiologists and the variability of their opinions concerning methods to reduce morbidity and mortality make it difficult to reach a consensus regarding standards of practice in anesthesia. Many authorities advocate the installation of sophisticated delivery and monitoring systems (as the airline industry has done), whereas others strongly oppose this approach and are convinced that safe anesthesia is a result of constant vigilance using relatively simple techniques. 4.6,12,13

Cost containment is a major factor, if not the major factor, preventing adequate development, purchase, and maintenance of state-of-the-art equipment and systems. 4

For an individual anesthetist or hospital, anesthetic mishaps are rare events. This fact greatly reduces continued interest in the problem among hospital medical staff and administrators. However, no matter how unusual an anesthetic death or severe injury may be, an individual occurrence is absolutely significant for that patient and family.

Few institutions-hospitals, anesthesia departments, professional associations, insurance companies, government agencies-are paying enough attention to these problems. However, a number of the issues discussed in this article are currently being addressed by a Task Force on Surgery and Anesthesia whose members represent the Joint Commission on Accreditation of Hospitals, the American Society of Anesthesiologists (ASA), the American College of Surgeons, the Association of Operating Room Nurses, the American Dental Association, the American Academy of Pediatrics, and other organizations.

Potential Solutions

In examining some of the potential solutions, it should be emphasized that funds needed for their implementation are not great when compared to the costs of medical liability and expenditures for long term care of the injured.

Compulsory reporting

It is important to establish mandatory systems for reporting anesthesia-related morbidity and mortality at local (hospital), regional, and national levels to provide data on the types and frequency of problems. This would allow anesthesia departments to take corrective action in risk management meetings examining mishaps, would encourage manufacturers to develop safer apparatus, would suggest that insurance companies reduce premiums for safe anesthetists, and would possibly allow anesthetists to choose anesthesia techniques on a statistically safer basis. The Joint Commission does require anesthesia departments to monitor and evaluate the quality and appropriateness of anesthesia patient care and to resolve identified problems. 14

Standards

Most authorities believe that there should be a greater local and national emphasis on writing standards for the practice of anesthesia. Such standards might call for the development and use of safer anesthesia machines with emphasis on human4actor design issues and safety-performance criteria as well as a better integrated monitoring systems(6).

Actually, at least three sets of standards have been promulgated in recent months. These include those of the physician-owned Mutual Insurance Company of Arizona, the Harvard Medical School Department of Anesthesia, and Hospital Shared Services, Inc, the risk management division of MultiMedical Insurance Company. Descriptions of the first two are available in an ASA pamphlet. "Examples of Approaches to Risk Management." In addition, proposed standards drafted by the joint Commission's Task Force on Surgery and Anesthesia are being circulated for review. The ASA has also established an Ad Hoc Committee on Standards of Care to consider the problem.

Monitoring

Many authorities believe that routine monitoring should include electrocardiograms, oxygen analyzers, disconnect and high-pressure airway alarms, automatic blood pressure recording devices (noninvasive whenever satisfactory), temperature thermistors, pulse oximeters, and capnometers. They recognize that some of these devices cannot be used with every anesthetic and that monitoring does not replace but rather augments vigilance on the part of the anesthetist. Any anesthetist can make a mistake that may be detected by an alarm before harm occurs.

Evidence now demonstrates that, for high-risk patients, invasive hemodynamic and respiratory monitoring as well as other specific techniques, accompanied by aggressive treatment, significantly decrease morbidity and mortality after anesthesia and surgery. (15,16) It is just as important, however, to establish standards for routine, noninvasive monitoring to promote safety in low-risk patients.

The question of what to monitor routinely during every administration of anesthesia is most difficult to answer because of differences in opinion among well-qualified anesthesiologists. When assessing the relative cost-effectiveness of commonly available monitoring devices (fail-safe technology) to detect events such as esophageal intubation, disconnection in the breathing circuit, and administration of a hypoxic gas mixture, Duberman and Bendixen found that the recommended equipment costs only about $7 per patient over the useful life of the instruments. 6 Clearly, compared with the staggering costs of medical liability insurance, that figure is minuscule. Of course, a fail-safe monitoring system may present its own problems. For example, when alarm systems are not integrated, warnings tend to be ignored; and when multiple units are attached, leaks may develop in the breathing system. Fully integrated systems, now becoming available, should provide greater safety.

It is appropriate here to mention specifically the recently marketed pulse oximeter, the capnometer, and devices for automated noninvasive measurement of blood pressure. Anesthetists are surprised by how often the oximeter registers desaturation during endotracheal intubation, after accumulation of bronchial secretions, with nitrous oxide washout, or upon arrival of the patient in the recovery room. Examples abound of large liability awards granted because of hypoxic events that could have been prevented by use of this device.

Oximetry should, however, be considered only as a supplement to techniques that more rapidly warn of inadequate inspired oxygen concentration, breathing circuit disconnects, and esophageal intubation. Capnography, for example, will indicate esophageal intubation within one breath, whereas it takes the pulse oximeter up to several minutes if alveolar oxygen pressure was previously high. Since hypertension and hypotension in patients with coronary artery disease are known to be associated with perioperative myocardial infarction, the more frequent determination of blood pressure that occurs with the use of automated blood-pressure-measuring apparatus after induction of anesthesia and during unstable periods may well decrease the incidence of infarction.

Certainly, vigilance is most important in anesthesiology; monitoring should never be more than a backup for the clinical acumen of the anesthesiologist. But we must recognize the major contributions that such monitoring devices can provide in reducing overall morbidity and mortality rates.

Multidisciplinary Risk Modification

In discussing cost versus quality of care, ECRI states,

Comparatively little is being spent by either government or professional organizations to make anesthesia safer. .(R)educed anesthesia mortality rates can be cost-effectively achieved, but only through the organized, coordinated efforts of hospital professionals, (ICAH), malpractice insurers, and the anesthesia community itself groups that rarely work cooperatively on patient care issues. (4)

Problems of anesthesia mishaps should, therefore, be vigorously attacked at every level.

Hospitals and departments of anesthesia should do the following:

*Include anesthesia equipment in risk management programs. This will require periodic testing, documentation, and reporting of problems; prompt repair by professional technicians under the supervision of biomedical engineers; mandatory use of preoperative checklists by operators; and well-designed, inservice training programs.

* Replace obsolete anesthesia machines and monitoring equipment. Some authorities estimate ten years to be the safe, useful life of an anesthesia machine. Certainly many old machines do not meet modern safety standards. ECRI states, "Anesthetists must often tolerate a wide variety of equipment, as well as deficiencies such as dangerously arranged controls and gauges conditions that would not be tolerated. . in commercial aviation, regardless of the costs of correcting the deficiencies. 4

* Establish effective morbidity and mortality conferences using data collected from listing all critical incidents. In addition, devote meetings periodically to overall patient safety issues.

* Emphasize in educational endeavors those engineering and functional aspects of anesthesia equipment that will result in better recognition of impending mishaps and the development of methods to prevent them.

Develop standards of practice.

Develop specific protocols, including guidelines for the exchange of anesthesia personnel and for anesthesia machine inspection procedures.

* Maintain rigid criteria for granting privileges to practice anesthesia.

* Employ enough technical anesthesia personnel to maintain equipment and provide assistance to the anesthetist when needed.

The ASA, the American Hospital Association, the American Medical Association, the Council of Medical Specialty Societies, and other concerned organizations should intensify their efforts to promote patient safety through strong educational programs for their members as well as continued evaluation of the effect of medical mishaps on ever-increasing medical liability premiums.

Medical liability insurance companies should lower premiums for anesthesiologists and hospitals that have effective anesthesia risk management programs, use superior monitoring systems, and follow proper standards of practice. In addition, insurance companies with adequate statistics should be able to recognize which departments or individual anesthetists sustain repeated mishaps and consider the addition of premium surcharges.

The Joint Commission should continue its current interest in anesthesia safety and its collaborative effort with the ASA and the other members of the Task Force on Surgery and Anesthesia to develop written standards for the practice of anesthesiology. Unfortunately, only by regulation will some anesthesia departments develop adequate standards of safety.

Government and other organizations should hasten the further development of safety and performance standards for anesthesia devices. This includes the establishment of standards for labeling ampules, vials, and syringes as proposed by the American Society for Testing and Materials Subcommittee D10.34.

Local and state governments should recognize anesthesia morbidity and mortality as a public health problem and establish statistical reporting systems. The Food and Drug Administration has issued a regulation requiring manufacturers and importers to report device-related deaths and serious injuries. It should enlarge its reporting system so that practitioners can anonymously record adverse anesthesia events.

Conclusion

The anesthesia profession shares many similarities with the airline industry, which has simply taken better advantage of risk management techniques and other technological advances. These include preflight checklists and other protocols, training in management of emergencies' with "in-f light simulators," and recording and tabulating critical incidents by means of the "black box" in-f light recorder. Perhaps this is why in the United States the average annual death rate from 1975 to 1980 for majorcommercial jetflights was only 177 per year.

In a January 28,1985, article about the disaster at the chemical plant in Bhopal, India, the New York Times noted that the accident resulted from design flaws, maintenance failures, training deficiencies, and operating errors. This is a good analogy of anesthesia mishaps, which also occur as a result of complex events with multiple possible causes. Only by improving our systems of training, monitoring, maintenance, and reporting, as well as by increasing our attention to human error, can we make anesthesia completely safe. This will require the vigorous efforts and close cooperation of all involved parties.

References

1. Snow J: On the fatal cases of the inhalation of chloroform. Edinburgh Med Surg 1 72:75,1849.

2. Pierce EC Jr: historical perspectives. In Pierce EC Jr, Cooper JB (eds): Analysis of Anesthetic Mishaps. International Anesthesiology Clinics. Boston: Little, Brown, 1984, pp 1-16.

3. Keenan RL. Boyan P: Cardiac arrest due to anesthesia: A study of incidence and causes. ]AMA 253:2373-2377, Apr 26,1985.

4. ECRI: Deaths during general anesthesia: Technology-related, due to human error, or unavoidable? Technology for Anesthesia 5:1-10, Mar 1985.

5. Pierce EC Jr: Reducing preventable anesthesia mishaps: A need for greater risk management initiatives. Risk Management Foundation Forum 6:6-8, Mar-Apr 1985.

6. Duberman SM, Bendixen HH: Concepts of fail-safe anesthetic practice. In Pierce EC Jr, Cooper JB (eds): Analysis of Anesthetic Mishaps. International Anesthesiology Clinics. Boston: Little, Brown, 1984, pp 149165.

7. Davis DA: An analysis of anesthetic mishaps from medical liability claims. In Pierce EC Jr, Cooper JB (eds): Analysis of Anesthetic Mishaps. International Anesthesiology Clinics. Boston: Little, Brown, 1984, pp 31-42.

8. Solazzi RW, Ward Rj: The spectrum of medical liability cases. In Pierce EC Jr, Cooper IB (eds): Analysis of Anesthetic Mishaps. International Anesthesiology Clinics. Boston: Little, Brown, 1984, pp 43-59.

9. Keats AS: Role of anesthesia in surgical mortality. In Orkin FK, Cooperman LH (eds): Complications in Anesthesiology. Philadelphia: Lippincott, 1983, pp 3-13.

10. Tinker IH, Roberts SL: Anesthesia risk. In Miller RD (ed): Anesthesia, 2d ed, vol 1. New York: Churchill Livingstone, 1986, pp 359-380.

11. Cooper IB, et al: Critical incidents associated with intraoperative changes of anesthesia personnel. Anesthesiology 65:456-461, Jun 1982.

12. Philip J H, Raemer DB: Selecting the optimal anesthesia monitoring array. Medical Instrumentation 19:122-126, May-Jun 1985.

13. Pierce EC Jr: Editorial: Standards for monitoring. Intelligence Reports in Anesthesia 3:3, Sep-Oct 1985.

14. Joint Commission on Accreditation of Hospitals (JCAH): Accreditation Manual for Hospitals. Chicago: JCAH, 1986, p 8.

15. RaoRLK,JacobsKJ,EI-EtrAA:Reinfarction following anesthesia in patients with myocardial infarctions. Anesthesiology 59:499-505, Dec 1985.

16. Slogoff S, Keats AS: Does perioperative myocardial ischemia lead to postoperative myocardial infarction? Anesthesiology 62:107-114, Feb 1985.

Reprinted with permission from Risk Management and Quality Assurance, a 152-page compendium of 26 related articles and a special publication from the Quality Review Bulletin, which is published by the

Joint Commission on Accreditation of Hospitals, 875 North Michigan Ave., Chicago, IL 60611, (312) 642-6061.
 

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Vienna M&M Meeting Studies Safety

by Jeffrey B. Cooper, Ph.D.

ICPAMM originated from a group that first met in Boston in October 1984, during the International Symposium (now Committee) on Preventable Anesthesia Mortality and Morbidity. The September ICPAMM meeting in Vienna was the planned follow-up of those original discussions. Sixty-two participants attended, representing 19 countries. The objective of this meeting and this informal organization is to enhance international communication of ongoing research in anesthesia mortality and morbidity and of patient safety activities. Such communication should stimulate innovation in planning research and in formulating strategies that will minimize the risk of anesthesia.

The meeting opened by addressing the question, "Are there differences in anesthesia mortality and morbidity among countries?" There were then reports of patient-safety activities and research in Canada, France, Holland, the United Kingdom and the United States. In the afternoon session, two discussion sessions were held: "How to Resolve the Monitoring Controversy9" and "Selection and Assessment of Anaesthesia." Plans were formulated for cooperative international surveys .

Death Rates

In the first presentation, Dr. Jeffrey Cooper compared estimates of anesthesia-related mortality and morbidity from studies in several countries. The major hypothesis was that there are not large differences in the rates of anesthesia M&M among the industrialized countries. Rather, differences suggested by results of various studies are primarily due to the differences in methodologies. It was argued that the approximate rate of anesthesia mortality among all patients is 1 per 10,000, but that the risk to the relatively healthy patient undergoing an elective procedure is probably on the order of 1/50,000 to 1/100,000. Dr. Cooper suggested that each medical "culture" has adopted practices that minimize the mortality rate to a level acceptable by its society By emphasizing how those different practices work in each culture, other countries can learn how to adapt some elements so that each could improve upon its current performance.

The reports of patient-safety activities strongly indicate that this a subject of international interest. Several major studies of anesthesia mortality, morbidity, or complications have recently been completed or are underway (France, Canada, UK) and others are planned (USA, West Germany). Dr. JM Desmonts reviewed data from the recent French study and emphasized how recommendations and actions were implemented from the results. Similarly, Dr. Jan Crul described how a Dutch national committee that he chaired reviewed available data and prepared recommendations from which standards of practice were implemented.

Dr. E.C. Pierce reviewed the extensive list of patient-mw activities in the United States: the ASA video-tape patient-safety program; analysis of closed anesthesia malpractice claims; completion of a manual on quality assurance; cooperative efforts between the ASA and US FDA Bureau of Devices and Radiologic Health to promulgate recommendations for pre-use inspection of anesthesia apparatus; organization of a task force which, in cooperation with the US Center for Disease Control, is planning a national study of the incidence of anesthesia mortality and morbidity; adoption of standards for minimal monitoring. Of special significance is the organization of the Anesthesia Patient Safety Foundation in October 1985.

Monitoring

Difference in national approaches to monitoring standards was noted. In Holland, standards require only what monitoring instrumentation must be available; in the USA, the standard proposed (and since approved) by the American Society of Anesthesiologists defines what actually must

monitored.

Drs. E.S. Siker and Keith Sykes took opposing views on the subject of the benefits and problems associated with the increasing use of monitoring instrumentation in anesthesia. Dr. Siker cautioned that those who ask, "Can we afford more monitoring?" should more rightly ask, "Can we afford not to have more monitoring?" Dr. Sykes urged that our financial resources were better spent on assuring adequate training of new anaesthetists. Not surprisingly, each debater took the opportunity during the discussion to counter his own original arguments, attesting to the complexity of the controversy. During the discussion, Dr. I.S. Gravenstein briefly described a study in progress investigating how the anesthesiologist processes information and acts upon it. Dr. Cooper noted preliminary results of an ongoing study suggesting that pulse oximetry had the influence of reducing certain types of complications.

Dr. Anthony Adams reviewed a list of criteria generated at the 1984 meeting for identifying appropriate candidates for anesthetists. But, his presentation stressed the more important need to identify the "wrong" people since the-se were the greater contributors to adverse outcomes. In the discussion, Dr. Ronald Katz reported his experience that, almost without exception, trainees dropped from anesthesia training programs complete programs elsewhere and eventually stay within anesthesia. Other discussants Confirmed the international prevalence of this phenomena. Several participants described attempts in various countries to have forms of "trial" period for prospective anesthesia trainees. This has the advantage of preventing entry into a formal program by individuals who are not well suited to the profession.

It was noted that the increasing supply of physicians, (experienced already in Europe, but also increasingly in the United States) will probably lead to a greater pool for selection of anesthesiologists. This is likely to generate a much greater emphasis on developing effective mechanism for selecting the right candidates.

Several projects were proposed for completion before the next meeting. There will be a renewed effort to develop standardized definitions for anesthesia related mortality and morbidity A renew by Dr. Stephanie Duberman in the book recently edited by Dr. John Lunn [see review in this issue] will be distributed to meeting participants. Dr. Adams will direct an effort to survey members of this international group about experiences with failures of anesthesia candidates. Also, various members will work to design a survey to identify the extremes and ranges of judgement for required monitoring in illustrative cases. Dr. Gravenstein will organize a survey to assess opinions of the maximum working hours for anesthetists.

The next meeting is scheduled for May 22, 1988, the day preceding the opening of the World Congress of Anesthesiology in Washington, DC.

Dr. Cooper, Massachusetts General Hospital, is on the APSF Executive Committee and is the organizer of ICPAMM.

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Current Questions in Patient Safety

Question We are in the process of designing new operating rooms at our community hospital. The architects have indicated that local building and fire codes require isolated power systems in the OR but our hospital biomedical engineer says isolated power systems are obsolete, expensive, and do not contribute to patient safety. Who is right?

Answer: In the most recent document from the National Fire Protection Association on standards for health care facilities (NFPA 99-1984), isolated power systems are no longer required in nonflammable anesthetizing locations. This document comprises a number of past NFPA individual pamphlets dealing with health care facilities and supersedes NFPA 56A. The NFPA is a not-for-profit organization that writes voluntary standards arising out of consensus among fire professionals, engineers, anesthesiologists, and other interested parties. As such, these standards have no weight of law, but are often adopted in part or as a whole by local governments and accrediting agencies having jurisdiction. Only then do they become "law" 'The NFPA has no power or authority to police or enforce compliance with their standards.

Regrettably, there is often a several-year delay between when NFPA reviews a document and when a jurisdiction incorporates the changes into the municipal or state fire or health facility code. Also, a government or agency is not obligated to accept the most recent NFPA revision. Given the lead time between planning and actual construction, effort should be made to lobby the local government or authority having jurisdiction to accept the new NFPA standards; a conventional grounded power distribution system is far less costly to install and maintain than an isolated power system.

The absence of an isolated power system in a nonflammable anesthetizing location will not put your patients at any greater risk. Remember that

isolated power systems were originally developed to reduce the risk of flammable anesthetic explosions. All isolated power systems required the use of a line isolation monitor (LIM) which continuously indicated the current that might flow to ground and create a spark were there a connection between the isolated circuit and ground. This could be as high as 5 milliamperes (mA) be-fore triggering the audible and visual alarms in each operating room. An "acceptable" hazard current of 4 mA to the LIM still was far in excess of the safe current limits established by the Association for the Advancement of Medical Intrumentation for the prevention of microshock (AAMI: Safe Current Limits for Electromedical Apparatus [American National Standard] {ANSI/AAMI ESI-1985)). Isolated power systems were never effective in preventing a dangerous microshock, whose magnitude may be as small as 10 microamperes (uA) in a susceptible patient.

The removal of the requirement for isolated power systems, however, did not remove the need for isolation transformers in electromedical equipment that comes into contact with patients. Nor does the inclusion of an isolation transformer in the design of a device guarantee the safety of the unit. AU hospitals should have an active biomedical engineering/risk management alliance that ensures all equipment brought into the hospital, whether purchased or on loan from a manufacturer, has been screened for leakage currents and is on an annual surveillance program. This is particularly critical with the encroaching use of equipment in the operating room that was never intended for direct patient care support, specifically the microcomputer. Errors in design and/or construction may result in extremely dangerous current leaks from device chassis (metal cabinet) to ground of greater than 100 uA.

Answer by David E. Lees, M.D., Professor and Chairman, Department of Anesthesia, New York Medical College and Chief, Westchester County Medical Center, and a member of the Newsletter Editorial Board.
 

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Foreign Correspondence:

Anesthesia Safety at the VII AACA

by Dr. Ross Holland Director of Anaesthetics and Resuscitation The Parramatta Hospitals Westmead, New South Wales, Australia

The 7th Asian and Australasian Congress of Anaesthesiologists was held in Hong Kong from 20-25 September. Present were more than 400 delegates from over 20 countries. The meeting was particularly strongly supported by anaesthesiologists from Japan, Australia, and the UK. Major contributions came from Hong Kong and the People's Republic of China.

Amongst the many seminars and panels of the five day program were several which took safety and monitoring as their theme. In Ross Holland's session, John Williamson (Australia) and John Gibbs (New Zealand) both challenged the traditional role of the EKG monitor intraoperatively. It was pointed out that in the ASA Class I or 11 patient, by the time the EKG gives warning of a hypoxic episode, the brain is already seriously injured, and indeed may have suffered irreversible damage.

On the other hand, once a crisis has occurred, the EKG may give invaluable information on the progress of resuscitation, Ode the use of drugs and other measures, and confirm the presence of sinus rhythm when circumstances make other methods less reliable.

From the New South Wales mortality committee's records, Dr. Holland presented data showing that almost exactly half of 624 deaths could have been prevented by the application of modern monitoring principles and practices. The other half could not have been so prevented, and the solution to these tragedies lies in education and training.

This paper triggered lively discussion, and brought Jeff Cooper, Ph.D. to the microphone to enlighten the meeting on the recently published mandatory minimal monitoring standards for the Harvard group of Hospitals.

Dr. Cooper pointed out that the differences in environment of anesthesia practice may modify the approaches taken to enhance safety, especially if anaesthesia is more often in the hands of untrained or partly trained practitioners.

At another session, on Quality Assurance, chaired by Bill Crosby (Geelong, Australia), delegates were advised of a number of strategies aimed at detecting departures from "normal" or satisfactory anaesthesia outcomes and methods for correction. The dependence of quality of care evaluation on adequate record-keeping was emphasized, as was the value of feed-back from recovery room nursing staff.

Discussion on the "accident-prone" individual as anaesthetist, and how to keep that person (if he costs) out of the anaesthesia work-force, stimulated great interest. Although the desirability of such exclusion was acknowledged, it was agreed that previous attempts at obje6vely assessing suitability prior to entry have not been validated.

Discussion from the sessions continued at an informal breakfast meeting. Dr. Cooper reported on the recent meeting of the International Committee

for Prevention of Anaesthesia Mortality and Morbidity in Vienna (see report on page 23). Dr. John Zorab described progress in the major study of perioperative mortality ongoing in the UK (CEPOO). Professor Crul brought news of the minimum monitoring standard now accepted in the Netherlands. This has effectively applied pressure on hospital authorities to provide appropriate equipment. Dr. Williamson reported that an expanded critical incident study is being organized in Queensland. The same type of study is also being planned in the UK using a "prospective" questionnaire.

The East and West contingents will be meeting together in 1988 at the World Congress of Anesthesiology.
 

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Notes

Puritan-Bennett Thanked

The Anesthesia Patient Safety Foundation Newsletter gratefully acknowledges the contribution of the Puritan-Bennett Corporation, Overland Park, KS, which provides facilities and the staff who typeset (Ms. Jennifer Stockstill), compose (Ms. Anita Cleland), print (Ms. Laurie Towns), and organize binding and mailing of the Newsletter (Ms. Joyce Gray). Special thanks to the supervising facilitators Mr. Scott Jensen and Ms. Caye Crosswhite.

Research Grant Applications Sought

The Anesthesia Patient Safety Foundation announces the deadline of May 15, 1987 for receipt of applications for research grants to start January 1, 1988. Grants are limited to $35,000.00, do not include indirect costs, and are for a period of one year only. Awards will be announced at the APSF annual meeting in October, 1987. Guidelines describing the scope of the grant program and application format may be obtained from the Anesthesia Patient Safety Foundation, 515 Busse Highway, Park Ridge, IL 60068.

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

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. Dew Rountree, Jr., Vice-President\; E.S. Siker, M.D., Secretary; Burton A. Dole, Jr., Treasurer; Jeffrey BL Cooper, Ph.D.; Joachim S. Gavenstein, M.D.; James E Holzer, J.D.

Newsletter Editorial Board:

John H. Eichhom, 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., E.S. Siker, M.D., Benard V. Wetchier, M.D., Mr. Mark D. Wood

Address general correspondence to: Administrator

Anesthesia Patient Safety Foundation 515 Busse Highway

Park Ridge, IL 60068

Address Newsletter comments, questions, letters, and suggestions to: John H. Eichhorn, M.D. Editor, APSF Newsletter Anesthesia, DA-717 Beth Israel Hospital Boston, MA 02215

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