Mortality/Morbidity Committee Reviews
International Safety Studies
Safety Prominent Again At ASA, October 17-21
Letters to the Editor
International Standards for Safe Practice Endorsed by WFSA
Scavenger is Often a Neglected Safety Device
International Standards for a Safe Practice of Anaesthesia
New York Peer Review Program Will Collect MD QA Data
APSF Names Executive Director
by Jeffrey B. Cooper, Ph.D.
This report is the fifth in a series summarizing meetings of the International Committee for Prevention of Anesthesia Mortality and Morbidity*.(1,2,3,4) This group meets periodically to review studies of anesthesia mortality and morbidity and to discuss issues related to anesthesia patient safety in countries throughout the world. The objective of the group is to provide a forum for discussing patient safety related issues and particularly for sharing experiences in conducting studies of adverse anesthesia outcomes. This year 48 invited participants attended, representing 16 countries. Some of the presentations focused on the methodology of studies previously published; others described studies that have not yet been reported. The afternoon session focused on crisis management.
MORNING SESSION: PATIENT SAFETY STUDIES
As in previous meetings, when previously published studies are presented, the speaker is asked to discuss issues of methodology, particularly those elements of the method that were especially successful or not so successful.
Randomized Trial of Pulse Oximetry in Copenhagen (Dr. Jakob Trier-Moller)
Dr. Trier-Moller briefly summarized the multicenter trial of pulse oximetry, which involves 20,802 patients divided into two groups: oximetry or no oximetry intraoperatively and through the stay in the PACU.(5,6) No differences were found in most intra-operative or post-operative events, but there was significantly more hypoxemia and more endobronchial intubations and myocardial ischemia detected in the oximetry group intra-operatively and more hypoxemia and hyperventilation detected in the oximetry group in the PACU. There were, however, no differences in any events between the two groups post-operatively. Dr. Moller addressed three methodological questions: was bias, the learning effect or the study design responsible for the absence of any differences?
Why No Improvement With Pulse Oximetry?
There were a few statistically significant differences in the characteristics of the patients in the two groups. These could have been due to violations of the randomization process. But, because the chiefs of the five participating anesthesia departments carefully monitored the study, it is believed that randomization violations were minimal and that differences in characteristics were due to chance. Did the staff learn from using pulse oximetry and apply new knowledge to the control group? That question was addressed by comparing the difference in the rate of events and differences in the way the patients were treated for each group. The rate of events in each group was stable throughout the study. Although oxygen therapy was ordered more often for the oximetry group, the rate of ordering for both groups was stable throughout the course of the study. Was the study design efficient? The estimate of Type 11 error was 10% for cardiovascular complications, 6% for respiratory complications and 0.2% for all complications with the premise of a reduction in rate of 25% and 2 a of 5%. Still, for the most serious post-operative complications, myocardial infarction and anesthesia-contributory death, which had incidences of 0.15% and 0.034% respectively, the sample size required for a statistical power of 90% with the same assumptions, would have been 500,000 and 1,000,900 respectively. Thus, to assess the effect of pulse oximetry on the most serious outcomes would require sample populations many times greater than used in this large study. Dr. Moller still believes the randomized control trial is the gold standard. But, to be effective, studies should be conducted on an international scale and should be restricted to study populations for which changes are more likely to be seen, e.g., patients with cardiovascular diseases, ASA physical status of III or greater, age greater than 60, upper abdominal procedures.
What has been learned about Reviewer Bias from the ASA Closed-claim study? (Dr. Frederick Cheney)
Dr. Cheney, one of the leaders of the ASA closed-claim studies, briefly summarized the history of this project, which started in 1985. Because the analysis of claims for identification of causes, assessment of the contribution of substandard care, and development of strategies for reduction of risk have all depended on independent reviewers, the investigators have examined the possible bias introduced by that process.(7,8) The report by Caplan, et al. used 21 cases from the entire set and altered the outcome of each from permanent to temporary or temporary to permanent.(9) One hundred and twelve reviewers judged, among other things, appropriateness of care for a set of cases that included only one version of each case. It was shown that the reviewers were much more likely to judge that care was inappropriate when the outcome was permanent rather than temporary regardless of which way the outcome had been changed from the original.
In another study,(10) the overall agreement of reviewers about appropriateness of care was examined, with pairs of reviewers independently examining the same claims' files. Although the agreement for all claims was fair to good, there was only slight agreement for claims in which there was only a temporary injury. The agreement on outcomes with permanent injuries was also fair to good, but this could be attributed to the greater tendency of reviewers to judge care inappropriate for such outcomes, as described above.
In the third related study, several questions were asked about how likely various types of monitors would prevent complications. Although the focus of the study was the question of the usefulness of capnography, it was again found that agreement on individual cases was poor. Dr. Cheney noted that in cases he has reviewed in which pulse oximetry was used, the cause is rarely attributed to 'inadequate ventilation' even though this label was the most frequently ascribed for serious outcomes in the closed-claim study. The implication is that pulse oximetry identifies the cause of an event as hypoxemia where otherwise that would not have been known.
In response to questions, Dr. Cheney noted that the study has emphasized individual reviewers because the U.S. legal system is so dependent on expert witnesses. He believes the study has demonstrated the underlying deficiency of that approach since there is so little agreement between expert reviewers about the standard of care. He suggests that practice guidelines are needed but recognized how expensive it is to create them.
Update on the Australian Incident Monitoring System (Dr. William Runciman)
As at previous meetings, Dr. Runciman reported on the progress in the ANS project which was started in July 1988 and now involves 80 hospitals in Australia. The plan is to report on the first 2,000 cases; presently, preliminary analysis has been performed on the first 1,500 cases. A meeting is scheduled this October for a thorough discussion of the study. Reportable incidents are any that did or could have resulted in the demise of the patient. A very detailed report form is used with many structured data items. Dr. Runciman noted the importance of the FOS (Person-C)n-the-Spot), who coordinates activities in each hospital, e.g., assures availability of forms, coaches clinicians in correct use of the forms, assists in gathering follow-up data, designs preventive strategies.
The pattern of incidents in many ways follows that of earlier critical incident studies regarding the type of incident, associated factors and preventive strategies. Dr. Runciman noted that 40% of events have no (undesirable) outcome, but that awareness, death or major morbidity were involved in 12% of events. The errors are categorized in various ways. As an example of items of interest, it has been found that the wrong drug was involved in 6% of events and 50% of those were potentially harmful. Surprisingly, in the majority of the cases, the wrong drug was injected from a syringe that was correctly labeled.
The project has been concentrating on the effectiveness of monitoring in identifying incidents and the mechanisms by which this happens. Some form of monitoring was responsible for detecting the event in 33%, 41% and 45% of the first, second and third set of 500 events, respectively, suggesting an increasing influence of monitoring in this regard. Of the events first identified by a monitor, the pulse oximeter, capnograph and ECG, in that order, are the three monitors most likely to have detected the event. In 70% of the events detected by a monitor, the pulse oximeter gave the first indication. Dr. Runciman commented that there are numerous incidents reported that involve a preventable death that otherwise will not be reported as an anesthesia related occurrence. He argued in favor of using incident reporting as the basis for understanding accidents since so much information is withheld when an actual accident occurs.
Update on the National Confidential Enquiry into Perioperative Deaths (Dr. John Lunn)
The NCEPOD** has been active since 1985, collecting reports of all deaths occurring within 30 days of operations in the United Kingdom, not including Scotland. Information about each event is reported by both the surgeon and anesthetist. Each year, a somewhat different sample is analyzed to focus on a different issue.(11,12) Dr. Lunn noted that they are no longer interested in searching for .causes' of anesthetic deaths because the variance in judgments is recognized to be too great, confirming the observations reported by Dr. Cheney earlier. Further, since it has been learned from earlier years of NCEPOD that anesthesia is rarely the sole cause of a perioperative death, the focus of efforts is now on quality assurance.
This year, the objective was to collect control cases for comparison to deaths of patients with similar characteristics and procedures. The method chosen was to select the first case performed by each surgeon every day. Unfortunately, it was recognized only later that this was not a random selection and introduced bias because many surgeons schedule their less complex cases for early in the day. Dr. Lunn noted another difficulty encountered in the last year was in gathering official data on the number of deaths as reported from the Department of Health to confirm the reports received by NCEPOD. Unfortunately, data separating patient deaths from hospital discharges are no longer available. Thus, there are now no accurate data on rates of deaths; changes in death rates cannot be measured. Further describing difficulties in conducting such a large scale study, Dr. Lunn noted the delays experienced in having the detailed questionnaires returned. One reason is that the system depends upon the surgeon providing the questionnaire to the anesthetist after a death has occurred. This communication is not always effective.
Although some changes in anesthesia practice have been instituted in the UK, Dr. Lunn felt that there had been too little response from clinicians or managers to the findings of NCEPOD. This year, the project will focus on 15 procedures, requesting detailed data on the most recently performed by each surgeon to collect a more random sample of control cases. The procedures selected for this sample are those in which it is known that there are differences in management between clinicians or hospitals.
Recent Advances in Anesthesia Safety in Poland (Dr. Jacek Jestrzebski)
Poland is confronted with a shortage of physicians and particularly anesthesiologists, of which there are only I per 20,000 population versus about I per 6,000-8,000 population in most European countries. Approximately 15% of anesthetics are administered by non-anesthesiologists and the distribution of anesthesiologists throughout the country is very unbalanced. This creates an extreme workload, with some anesthesiologists working more than 85 hours per week in smaller hospitals. There is also a shortage of centralized operating rooms, so anesthesiologists often must move between distant locations. Over 50% of anesthesia machines are greater than 20 years old and there are shortages of drugs and other equipment. Thus, the focus of safety efforts has been on education. Five years of practical and specialty training is required of physicians before the specialist exam can be taken. In Dr. Jastrzebski opinion, more important for patient safety has been the emphasis on regional anesthetic techniques. The use of regional anesthesia has increased from 8% from 1971 through 1980 to 35% during 1981 through 1990. Using data collected from 17 hospitals in 3 districts, representing a total of 5,700 beds, Dr. Jastrzebski reported that the complication rate has decreased from 0.6 to 0.47 per 10,000 patients during these two time periods. Similarly, the anesthesia-related rate of mortality has decreased from 1.29 to 0.35 per 10,000 patients. Dr. Jastrzebski attributes this finding not only to the emphasis on all regional techniques, but particularly on training and techniques other than spinal and epidural anesthesia. In response to questions, Dr. Jastrzebski explained that the data is reported by the chiefs of the various hospitals, who use the anesthesia records as their primary source of information.
Anesthesia Deaths and Complications in St. Petersburg (Dr. Alexander Dizhe)
With Uvarov and others, Dr. Dizhe previously reported on the causes of deaths in the operating room in a number of medical institutions (presumably in the same region) during the period 1973 to 1985. This report is based on a similar study conducted during the period 1986 through 1991 in St. Petersburg. The investigations are based on retrospective analysis of anesthesia records. But, the absence of important information from the records and the lack of complete monitoring make it difficult to analyze these cases.
This report is based on 121 cases of death in the operating room (not including the perioperative period). About 42% of procedures were urgent; the perioperative condition of 118 patients was labeled as 'serious'. Fifteen percent of the cases were said to be associated only with anesthesia, 25% indirectly associated with anesthesia and 60% were primarily a result of complications of the surgical intervention, including cases of trauma with uncompensated blood loss. The 48 cases in the first two groups are described further. The pattern of deaths was similar to that in the previous study. In 13 cases, the primary reason for death was related to respiratory insufficiency. Among these, there was obvious evidence of the need for artificial ventilation in three although the patient was allowed to breathe spontaneously. Three cases involved aspiration, two migration of the tracheal tube and two others pneumothorax.
Other cases of anesthesia related death were distributed among other causes that are typically reported including hypovolemia in association with epidural or spinal anesthesia. Anaphylaxis was identified in only one of the cases. Among the second group of cases, where anesthesia was only partially responsible for the death, 20 appeared related to cardiovascular collapse at the onset of surgery or shortly thereafter. Overall, Dr. Dizhe reports that the frequency of lethal outcomes associated with anesthesia during surgery appears to fluctuate between I per 10,000 and 4 per 10,000 among the institutions studied. He cites as the major factors for these variations in rate the differences in degree of specialist training, organization of assistance and maintenance of equipment.
Anesthesia Mortality and Morbidity in Japan (Dr. Yasuhiro Shimada)
This was the first report to ICPAMM of data on anesthesia mortality and morbidity in Japan. Dr. Shimada, after accepting the invitation to participate in the meeting, was surprised to realize there has been no systematic research on anesthesia outcomes or mishaps in his country. Thus, he used the occasion of this talk to conduct his own inquiry. Dr. Shimada first briefly explained the organization of anesthesia care in Japan. Although any physician can anesthetize patients, the title of anesthesia specialist is conferred, only after two years of residency and must be ,followed by a continuing training program of throe years. The title of board certified anesthesiologist is conferred only after successful completion of written and oral examinations. There is a substantial shortage of anesthesiologists in Japan; of 870 hospitals with operating rooms, only 500 have at least one board certified anesthesiologist. Although information on closed claims is collected by the Japan Medical Association, these were not available for examination. The Japan Society of Anesthesiologists was planning to initiate an inquiry of anesthesia accidents beginning in July 1992, but this will include only board-certified anesthesiologists. Thus, Dr. Shimada turned to information from the Medical Malpractice Information Center, established by a group of lawyers specializing in medical malpractice. He sent a questionnaire to 215 lawyers from this group and has, to date, received a response from 59%. A total of III case summaries were reported, however, only 64 had sufficient detail to permit analysis. In these, anesthesia accidents were defined as involving either cardiac arrest, hypotension or hypoxia necessitating special treatment and other critical events. Twenty of the suits involved anesthesiologists; in the other 44, the anesthesia was administered by a non-anesthesiologists. The cases in both groups were examined separately.
Of particular note was a large number of cases of cardiac arrest and hypotension involving spinal anesthesia administered by non-anesthesiologists (21 cases). Within this group of providers, 24 of the cases involved death and severe damage. For anesthesiologists, general anesthesia was administered in 17 of the cases; 6 resulted in death. Among both types of providers, the records suggest that monitoring which is standard in other countries is not always used, e.g., in 24 cases involving non-anesthesiologists there was no ECG monitoring, temperature monitoring was not used in any of the cases, BP monitoring was used in 37 (of the total 44). For anesthesiologists, these standard forms of monitoring were applied more frequently, but even though the date of occurrences are from 1974 to the present, no case involved the use of a pulse oximeter or capnometer. Human error was the most frequently cited cause of the adverse outcome. Dr. Shimada observed that bradycardia and cyanosis were frequently the first indication prior to the onset of cardiac arrest, suggesting that the pulse oximeter could have been useful in preventing the problem. Inadequate air-way management was often related to intubation failure. For cases involving hypoventilation, seven involved a high spinal anesthetic. For cases involving hypovolemia, eight were associated with spinal anesthesia with severe hypotension and/or cardiac arrest.
Dr. Shimada noted his dismay at realizing the lack of information about anesthetic outcomes in Japan and the relatively undeveloped state of monitoring. Not surprisingly, he suspects that these cases represent only the 'top of the iceberg'. There are now about 300 new cases of medical malpractice reported annually with a total of 1,600 cases still pending resolution. Of the cases completed during the period 1980 through 1986, about 30% to 35% are won by the plaintiff annually. Among the cases examined in this report, the largest payment was about one million dollars.
During the discussion, Dr. Michael Rosen added further insight to the situation in Japan. He and Dr. M. Fugimori have reported that the mortality in Japan is four times higher than that in England and Wales. Data from both countries is available although that from Japan does not identify causality. Yet, if anesthesia in Japan is the cause of death among the same proportion of all cases as in the UK and Wales, about 160 such anesthesia related deaths occur annually. Conversely, the neonatal fatality rate is the same as that in England and Wales. This may result from the extreme shortage of anesthesiologists, who are in much shorter supply per capita in Japan, versus obstetricians and pediatricians, of whom about the same number are available per capita as in England and Wales. Dr. Naosuke Sugai commented that one of the main reasons for the shortage of anesthesiologists in Japan is that they are not permitted to practice privately.
The general discussion focused on two suggestions: a taxonomy for outcome and incident studies and the development of a generic incident report form. The former topic was the focus of the first meeting in 1984. That produced some agreement on definitions for anesthesia-related death and morbidity. But, Dr. Lunn observed that the term 'anesthesia death" is still being used even though it is inappropriate since patients rarely die solely from the anesthetic. There was strong support for creation of a generic form, perhaps based on the numerous such instruments, e.g., from the AM, ASA closed-claims study, CEPOD and critical-incident studies. Several participants volunteered to join a task force to work on these issues.
There were several comments about the impact of ICPAMM on members of this group. Anecdotes were told of how information disseminated from the group has been useful in developing methods for studies in other countries and in influencing public health authorities. A question was asked of how this group could be helpful to countries that did not yet have active patient safety efforts. Based on the experiences of those who have participated in ICPAMM, it was felt that ICPAMM could be most effective by making available information on methodology so that other countries could establish their own systems for data collection. The comment was made that publications from other countries are not typically useful to influence any one government. Rather, each country must collect its own data to convince authorities that a problem exists. The lessons learned from studies reported through this series of ICPAMM meetings should be applied to future investigations. Despite the great difficulties, which have deliberately been the emphasis of discussions in these meetings, collection of information about outcomes was generally felt to be important and influential in the countries that have done this work.
The participants agreed to meet again at the European Congress of Anesthesia to be held in Jerusalem in 1994. It was suggested that, given the change in leadership of the WFSA Committee on Safety, the efforts of ICPAMM be coordinated with the WFSA. For information about participation in ICPAMM or reprints of previous reports or information about any of the studies described, contact Dr. Cooper at Massachusetts General Hospital Department of Anesthesia, Boston, MA 02114 USA.
Dr. Cooper is Director of Anesthesia Technology and Director of Biomedical Engineering at Massachusetts General Hospital; Associate Professor of Anaesthesia, Harvard Medical School; Member of the APSF Executive Committee and Co-founder and organizer of ICPAMM.
1. Keats AS and Siker ES: International symposium on anesthesia mortality and morbidity. Anesthesiology 1985; 63:349-350.
2. Cooper JB: Conference Report 1986 Meeting of the International Committee for Prevention of Anesthesia Mortality and Morbidity. Can j Anaesth 1988; 35:287-93.
3. Cooper JB: Report of a meeting of the International Committee for Prevention of Anesthesia Mortality and Morbidity. Anaesthesia 1989; 44:441-443.
4. Cooper JB: ICPAMM Meets in Poland, Preventive Safety Studies. APSF Newsletter 1990; 6:32-35.
5. Moller JT, Pederson T, Johannessen NW, et al: Pulse oximetry does not reduce post-operative complications. A prospective study of 20,802 patients. Anesthesiology 1991; 75:A867.
6. Moller JT, Ravlo 0, Jensen PF, et al: Pulse oximetry uncovers hypoxemia and decreases the incidence of evidence for myocardial ischemia during anesthesia A prospective study of 20,802 patients. Anesthesiology 1991; 75:AI057.
7. Caplan RA, Posner K, Ward RJ and Cheney FW: Peer review of major anesthetic mishaps Evidence for consensus on basic issues of clinical management. Quality Review Bulletin 1988; 14:363-368.
8. Cheney FW, Posner K, Caplan RA and Ward RJ: Standard of care and anesthesia liability. JAMA 1989; 261:1599-1603.
9. Caplan RA, Posner KL and Cheney FW: Effect of outcome on physician judgments of appropriateness of care. JAMA 1991; 265:1957-1960,
10. Cheney KL, Caplan RA and Cheney FW: Physician agreement in judging clinical performance. Anesthesiology 1991; 75:AI057.
11. Buck N, Devlin HB, Lunn JN:The Report of a Confidential Enquiry into Perioperative Deaths. The Nuffield Provincial Hospitals Trust, 3 Prince Albert Road, London, 1987.
12. Campling EA, Devlin HB, Hoile RW and Lunn JN: The report of the National Confidential Enquiry into perioperative Deaths, NCEPOD (London), 1990.
*This meeting was sponsored by the Anesthesia Patient Safety Foundation.
**To purchase the 1990 Report of the National Confidential Enquiry Into Perioperative Deaths, send a check payable to NCEPOD in the amount of 9.00 pounds (in the UK) or 10.00 pounds (overseas) to National Confidential Enquiry Into Perioperative Deaths, 35-43 Lincoln's Inn Fields, London WC2A 3PN (Tel: 071-831 6430 Fax: 071-430 2958).
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by John H. Eichhorn, M.D.
Patient safety retains its prominent place on the program of the American Society of Anesthesiologists (ASA) Annual Meeting this year in New Orleans.
In the ASA Refresher Courses on Saturday, October 17, there are three particularly pertinent presentations: J.L. Benumof, M.D. will speak on 'Management of the Difficult Airway: The ASA Algorithm;' R.A. Caplan, M.D., one of the principal investigators of the ASA Closed Claims Study, will present 'Adverse Outcomes in Anesthetic Practice: What Are the Data? Can Outcome Be Improved?" and J. Ehrenwerth, M.D. will lecture on 'Electrical Safety in the Operating Room."
On Tuesday morning, October 20, there will be a panel discussion entitled "ASA Closed Claims Project: Impact on the Practice of Anesthesiology.' Among the distinguished speakers will be F.W. Cheney, M.D., who is chairman of the ASA Committee on Professional Liability and the main organizer of the study. Also, Dr. J.B. Cooper will speak on the methodology of dosed claims analysis and E.C. Pierce, Jr., M.D., President of the APSF, will discuss 'The Impact on Patient Safety.' Integral to this significant session will be the opportunity for questions, discussion, and observation from ASA members. It is anticipated that this will be an extremely interesting panel.
Also on Tuesday will be a Clinical Update Program titled "Risk Management in Anesthesia" given by J.H. Eichhorn, M.D. in which patient safety and quality assurance issues will be related to medical-legal concerns.
Another panel discussion, this one on Wednesday morning, October 21, concerns airway fires. In addition to presentation of information about ignition and combustion, there will be discussion of clinical experience with airway fires and suggestions for anesthesia techniques in dangerous situations.
A substantive discussion of a subject that is receiving a great deal of attention as human factors are considered more and more in regard to anesthesia care is expected during a panel discussion Tuesday afternoon, October 20, entitled 'Vigilance: Euphemism or Science?' Audience members will be able to contemplate the potential impact on safety of presentations regarding neuropsychological, environmental, and task-related factors which might affect an anesthesiologists' vigilance in the O.R. Automation in the O.R. and the mechanism of decision making will also be considered.
Among the scientific presentations in the section "Patient Safety, Epidemiology, and Education," there are three oral paper presentations, two poster sessions, and one poster-discussion session with a total of 89 individual presentations in the six sessions.
Several papers will deal with problems of unintentional hypothermia in anesthetized patients and its consequences. One study examines the likelihood of central vascular perforation based on the type of tip on a CVP catheter. The complications associated with axillary block are discussed in a poster presenting a review of 17,750 of these block procedures. Another poster likely to attract considerable attention is entitled "Adverse Experiences of Recovering Physician Addicts /Alcoholics in the Perioperative Period"
Complications of epidural analgesia when instituted specifically by residents will be covered in a poster. Another paper examines the epidemiology of intraoperative bradycardia in infants. Hypoxemia during 'conscious sedation" with midazolam and diazepam will be examined in an oral paper presentation. Another presentation will examine using transesophageal echocardiography to look for pulmonary embolization associated with the use of limb tourniquets for orthopedic surgery.
Analysis of adverse events by two raters for 26,841 patients in a multicenter study will be the subject of a Monday afternoon poster. The diagnosis of patient latex allergy will also be discussed. Additional new methods intended to improve the prediction 4f malignant hyperthermia susceptibility are covered in several presentations. Factors predisposing to abscess formation after epidural block will be covered in another paper. Following up on past presentations, there will be a paper on exactly how carbon monoxide can be produced in an anesthesia breathing circuit.
Studies regarding the use of laryngeal masks in airway management will be among the first presented in this country while several other papers deal with various aspects of intubation and techniques for confirming correct endotracheal tube placement. (Also, papers in the Equipment, Monitoring, and Engineering Technology section deal with using capnography as an aid to blind nasal intubation and with a new device to detect esophageal intubation.)
A presentation in the poster-discussion session is titled simply, 'Fire in the Operating Room!' Also, a frequent question will be reexamined by a study looking at lower extremity nerve injury associated with the Lithotomy position.
A potentially significant paper related to the recent major interest in anesthesia simulators is entitled "Can Simulation Accelerate the Learning of Basic Anesthesia Skills by Beginning Anesthesia Residents?' In the Equipment section, there will be a poster on the hearing acuity of anesthesiologists as it relates to alarm detection. Also in that section will be two papers on the use of artificial neural networks to analyze the effects of anesthetics.
In all, the recent tradition of significant emphasis on patient safety at the ASA meeting dearly will continue this year.
Dr. Eichhorn, APSF Newsletter Editor, is chairman of anesthesiology
at the University of Mississippi Medical Center, Jackson MS.
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Apnea Issue More Important Than Monitors. Capnography Standard Assailed as Obscuring Question of Professional Judgement
To the Editor
The article 'From the Literature: 'Standards of Care and Capnography" appearing in the Summer 1991 issue of the APSF Newsletter provokes my concerns about 'standards' and the concepts such standards generate to the point that I must write to live with my conscience. This review of a case report in a malpractice newsletter describes another case in which an esophageal intubation resulted in severe brain injury. This led to a judgement against the hospital for not providing a capnograph in 1987 and a 4.5 million dollar award to the plaintiff.
My comments are not at all directed to the appropriateness of the award or even whether a capnograph would or would not have been essential in the management of the case. Rather, my comments are incited by the fact that in the whole discussion of this matter in the review, there is no debate or even mention concerning the decision to render this patient apneic to the extent that mechanical ventilation was required. She is described as a healthy, 36-year-old woman for elective tubal ligation. She suffered a tragic outcome as a result of poor anesthesia care and the debate seems to be exclusively about the presence or absence of an electronic monitor and whose responsibility that was.
It is my contention that a basic fault here is in the decision to render a healthy patient totally apneic for a very minor surgical procedure. At the risk of being labeled macho, I insist that complete apnea is certainly not required for tubal ligation. Cardiac arrests and/or deaths from disconnects and esophageal intubation are not likely to happen if patients can breathe on their own. Therefore, these complications must in large part be attributed to the apneic techniques of anesthesia so commonly used today. Such potentially dangerous techniques that involve their own set of complications should be used only when specifically indicated since they do add significantly to the risk of general anesthesia. The extreme emphasis on monitoring dilutes or distracts attention away from the primary risk factor inherent in the anesthetic itself.
For the profession of anesthesiology to discuss this case without even mentioning the correctness of anesthetic management is likely an inevitable consequence of mandated standards. The standards make it 'legal' and easy for us to blame something and someone else. To me, this is unacceptable professional behavior.
We have come to accept and teach such clinical practices without appreciating the inherent dangers. I profess we have substituted reliance on monitors (encouraged by 'official' blessing from foundations and societies) for the individualization of indications and the weighing of risk-benefit ratios. Some more cynical than I might suspect an organization such as yours, which includes among its sponsors many purveyors of monitoring equipment, of a sinister method of marketing. A $4.5 million judgement will scare lots of hospitals into buying capnographs. 1, knowing you all to be above such behavior, limit my charges to grossly improper emphasis in determining the genesis of this tragedy.
I know your foundation did not render the decision and award. However, you have presented it without the above critical discussion. You have listed the questions raised without mention of the anesthesiologists professional judgement except as it relates to capnography. You have referenced the APSF Newsletter as repeatedly announcing and promoting the need for monitors. Did you ever admonish us as to the risk-benefit of apneic techniques? Have you considered 'standards" relative to prohibiting the subjecting of patients to this risk unnecessarily?
Many people are aware that I supported the development of capnographs. I believe they can and do give us valuable information. I am seriously saddened to see them promoted to the exclusion of professional judgement.
William K. Hamilton, M.D.
University of California, San Francisco
Soda Lime Needs Monitor
To the Editor
Recently, I had an occasion to discuss with a representative of a major anesthesia machine manufacturer the need for a more appropriate soda lime monitor. I suggested to him that with the present technology in the machines there should be no problem analyzing the C02 absorber for failure of the soda lime.
I have now decided that this idea should not be available to only one machine manufacturer. Since it was originally my idea and something which to my knowledge is not yet on the market, I am sending the idea to you so that it can be published and made common knowledge. Therefore, one manufacturer could not patent the idea or technology.
I myself have repeatedly gone to the assigned OR to find that the soda lime is exhausted to the point that the indicator dye is no longer effective. When brought to the attention of others, I get the response that this must be the reason their last few patients had such rapid pulses. I don't really know why the expired C02 level wasn't elevated to a point that they should have been suspicious, but evidently it wasn't.
In this proposed design for a more appropriate soda lime monitor, the soda lime canister is connected by three vents with tubing to a sampling valve with two outlets. Using a continuous C02 monitor, failure of the C02 absorbent in the canister could be detected without relying on the indicator color change within the canister.
In any event, the idea is simple and I encourage someone to develop it. If I wasn't at retirement age and still worked in a teaching hospital, I feel that it could be functional within a month of starting with off the shelf components.
Richard D. Thomason, M.D. Elkhart, IN
Dangers of Endoscopy Sedation Not Appreciated
To the Editor
Should anesthesia personnel be involved in conscious sedation methods for endoscopy? This is, I believe, a misframing of an important issue.
Prior to going into anesthesiology, I had planned to do internal medicine. As a result, I spent a great deal of time working with cardiologists, pulmonologists and gastroenterologists. I saw cardioversion performed once with the patient having received 20 mg Valium and being left obtunded for 30 hours. I once saw a patient with severe AS/MS (rheumatic heart disease) code and die because of what I believe to be panic, with no reserve to mount a sufficient cardiac output in the face of massive catecholamine release. The cardiologist had given the patient a 'safe' dose of 2.5 mg Valium IV.
Let's see... There were bone marrow biopsies and aspirations, grindingly done with nothing but local anesthesia (I didn't realize that local anesthetics worked well on the periosteum).
For colonoscopy I saw internists give Demerol/Valium and later Demerol /Versed cocktails. The results: the vast majority of colonoscopic procedures evoked responses consistent with significant pain. I saw patients groan, squirm, cry out and shed tears.
Do internists know how to use opioids? Prior to PCA, most internists used to order Demerol 25-50 mg q3-4 hr (early 1980s) for "alleviating' painful conditions.
The fact is, few internists know anything about sedative/amnesic/analgesic drug management. They have developed ever-increasingly invasive procedures with no sensibility about the pain and discomfort they cause. ('Hold still, Mrs. Jones, this won't take much longer .... Don't move Mr. Smith, we're almost there.').
What has happened is the same process as putting a frog in a pan of water and heating it up slowly. Internists have gradually come to do more invasive procedures over time, and if just a little more pain occurs than for less invasive procedures, that should be quite all right.
I challenge any endoscopists to face reality: What are the endpoints at which you would say that better anesthetic/analgesic regimen is needed than you are capable of giving? You don't have an answer to that. You've never even thought about doing a visual pain analogue study.
Is amnesia equivalent to adequate anesthesia? Of course not, except to internists. Yet if it were not for Versed, I dare say very few patients would return to their endoscopists for repeat checkups. Even with Versed, I would argue that if patients' families saw what occurred in endoscopy suites, they wouldn't let Grandma go back.
As anesthesiologists, we sometimes use amnesic agents to cover up a weak block, but we don't make it a daily practice. The anesthesiologist whose patients writhed under the surgeon's knife on a routine basis would be someone who would quickly develop a 'doesn't know what he's doing' reputation among surgeons.
In the wake of numerous mishaps at the hands of endoscopists in the mid-8N, procedural and post-procedural monitoring standards were enacted in most hospitals, and Versed-dosing guidelines were downscaled. (Did it take a warning from Roche to tip anesthesiologists that 0.3-0.7 mg/kg of Versed was an overdose? Then why didn't endoscopists figure this out on their own, as we did in 1985, if they really knew what they were doing?)
Few anesthesiologists today perform anesthesia services for endoscopy, because of insurers' unwillingness to pay for it. Yet who has done cost benefit studies, whereby propofol/mivacurium was used and compared to Demerol/Versed, in order to bring evidence before insurers supporting anesthesiology in the GI suite ? My guess is that the procedural and recovery times saved would make general anesthesia very competitive on a pure cost basis, and it would be greatly superior if quality of effect was counted, much as quick GA for cardioversion has proven itself. (Surgeons have known for years that a non-moving target is easier to operate on.) Moreover, as most endoscopy patients are elderly, it makes sense to have someone properly monitor them and be ready to treat any pulmonary or cardiovascular events, while the internist tunnels his way deep into the patients bowel.
We need to educate our internist colleagues, truly educate them, by getting in -and helping them do the job properly. The primary reason why anesthesiologists don't give anesthesia for GI endoscopies is because neither internists nor anesthesiologists are used to working with each other. Yet, if we throw out the barriers of inertia and tradition, and focus on the needs of patients, it is dear that we need to build some new service bridges.
Mark P. Schooley, M.D. San Juan Capistrano, CA
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by J. S. Gravenstein, M.D.
From time to time this Newsletter has published reports from other countries describing efforts to enhance safety in anesthesia. The World Federation of Societies of Anesthesiologists (WFSA) has also identified patient safety as an important issue and has had a Committee on Safety (now renamed the 'Committee on Safety, Equipment, and Technology"). Recently the WFSA and its Committee on Safety, Equipment and Technology received a document entitled 'International Standards for a Safe Practice of Anaesthesia', drafted by an independent International Task Force on Anesthesia Safety. This Task Force was composed of representatives from Australia, Canada, Finland, France, Germany, Japan, The Netherlands, UK, and USA. The authors of the document were well aware that international safety standards must take regional conditions into account and that some anesthesia providers must work with severely limited resources. One interesting aspect of this document, therefore, is which features the authors thought so important as to recommend them even to those working with the most limited resources. Also of some interest is the listing of recommendations concerning the anaesthetist and his/her professional world. Clearly, the authors assume that the anesthetist whether specialized physician, nurse, or untrained helper must command professional standing in order to execute his or her anesthetic responsibilities with the greatest possible safety.
This document was not intended as the wording of worldwide standards. Instead, it is intended as a model for international minimal standards, for intraoperative monitoring as well as for most other basic components of anesthesia practice which could be virtually universally applicable throughout the world. The authors hope that these standards will stimulate discussion of the many facets of anaesthesia that have an impact on safety. Perhaps some anesthesia groups or departments or national societies will find the document or parts of it helpful as templates in the formulation of standards where such standards do not yet exist or where they need to be modified.
At the June 1992 meeting of the WFSA in The Netherlands, these standards were accepted by the Executive Committee of the WFSA. This endorsement by the WFSA lends considerable weight to the message for safety in the document.
Dr. Gravenstein, University of Florida, is chairman of the WFSA Committee on Safety, Equipment, and Technology.
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Both Too Much or Too Little Suction Can Constitute a Hazard
by Clayton Petty, M.D.
Without a doubt the most neglected safety device of the anesthesia machine is the scavenger. As you visit anesthesia personnel at work in the operating room, it is rare to see even experienced anesthesiologists adjusting the rate of suction for the scavenger device. Usually the suction rate is set and left for a number of days until someone just happens to readjust the knob during a long case. During this time the suction is either too high (creates undo negative pressure in the system unless the negative pressure relief valve opens to admit room air) or the scavenger reservoir bag is overfilling (creating a high positive pressure unless the high pressure relief valve opens to allow the anesthetic gases to escape into the room). When the reservoir bag is flat because of excessive suction, the anesthesiologist usually does not take notice of the situation. The 'hissing' noise of escaping anesthetic gases through the scavenger's high pressure relief valve usually attracts attention and the suction flow rate is properly adjusted. Ideally the reservoir bag should be half-full and expanding-deflating without releasing gases to room air or allowing room air to be suctioned into the reservoir bag.
Scavenger systems were forced on anesthesia machines by the 'recommendations' of the National Institute for Occupational Safety and Health (NIOSH). The recommendations for room air concentrations of waste anesthetic gases is 25 ppm for nitrous oxide and 2 ppm for halogenated agents.(1) Amid a flurry of articles relating to the effects of waste anesthetic gases on operating room and dental personnel, the .recommended standards' became effective. However, scavengers have not been shown to change the occupational hazards of waste anesthetic gases to operating room personnel. Despite controversy, scavengers are here to stay. Hospital risk managers would rather have scavengers in place than face the possibility of a NIOSH fine or a liability lawsuit from an employee.
Two Types of Scavengers Create Different Problems
Scavenging systems are either passive or active.(2) Passive systems have a large tube or canister with an inlet, an outlet, and one open end. The waste anesthetic gases from the ventilator and 'pop-off' valve enter the inlet. Suction is applied at the outlet. If the suction rate exceeds the rate of entry of anesthetic gases, room air is drawn into the open end. If entry of anesthetic gases exceeds the rate of suction, excess gases exit via the open end into the room.
Active systems contain negative and positive relief valves to release excess pressures. (3) Active systems have been associated with higher exposure of gases in the environment than passive systems. (4) When the reservoir bag overinflates due to an excess inflow of anesthetic gases, pressure increases until the positive pressure relief valve opens to vent excessive gases into the room. A valve malfunction will allow the pressure increase in the patient circuit to increase to the limit of the elastic properties of the particular reservoir bag. High pressures can be detected in the patient circuit by the circuit pressure gauge and/or by the high pressure gauge of the ventilator. If high pressure persists the patient may develop decreased cardiac output secondary to high intrathoracic pressure, and/or pneumothorax.
When the suction rate exceeds the anesthetic gas inflow rate, the reservoir bag deflates. Usually any excessive negative pressure is offset by room air entering the negative pressure relief valve. Some scavenger systems have a second or backup relief valve. The pressure gauge of the ventilator may detect an excessive negative pressure state. If the negative pressure relief valve system malfunctions, it could be possible for the suction to remove anesthetic gases from the patient circuit.
It behooves us to be aware of the dangers inherent in the scavenger systems of our anesthetic machines. Anesthesiologists have a multitude of distractions which are much more critical to patient safety than the status of the scavenger. Pollution of the operating room environment with 'short bursts" of waste gases remains a consideration but should not supersede the safety of the patient. Be alert and cognizant of the relationship of a properly functioning scavenger system to the safety of the patient and to those who work in the operating room.
Dr. Petty, Professor of Anesthesiology, Uniformed Services University of Health Sciences, Bethesda, MD, lives in Salt Lake City, Utah.
1. NIOSH. Occupational exposure to waste anesthetic gases and vapors. Publication No. 77-149. Cincinnati. United States Department Public Health Service, Center for Disease Control, 1977.
2. Petty C: Scavenging and Pollution. The Anesthesia Machine. Churchill Livingstone, Inc., 1560 Broadway, New York, NY 10036.1987.
3. Waste Anesthetic Gas. Technology for Anesthesia 12:1-4,1991. ECRI. 5200 Butler Pike, Plymouth Meeting, PA 19462.
4. Are ambient anesthetic gases an occupational hazard?
BioMed Safety & Standards 1992; 22:49-51.
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These Standards of Care are recommended to anaesthetists throughout the world. Their purpose is to provide guidance and assistance to anaesthetists, professional societies, hospital administrators, and governments in improving the quality and safety of anaesthesia.
For some anaesthetists, these Standards will represent a future goal, while for others they may already have been implemented and be regarded as mandatory. The most important standards relate to the individual anaesthetist. Monitoring devices play an important part in safe anaesthesia as extensions of clinical skills rather than their replacement.
Minimum standards, indicated in bold, are applicable to any preplanned anaesthetic, from patient evaluation to recovery; it is recognized, however, that immediate lifesaving measures always take precedence in an emergency. Further recommendations should be implemented as resources and training permit: highly recommended standards should be implemented first, followed by those which are recommended, and then those that are encouraged. (A Glossary of terms used in this document is given in Appendix A.)
It is anticipated that these standards will need revision as practice and technology evolve.
1. Professional Status
The provision of anaesthesia is a vital component of basic health care and merits an appropriate share of the available resources. It is highly recommended that anaesthetists should be appropriately trained and accredited medical specialists with clinical and administrative autonomy. Where anaesthesia is provided by other personnel, it is highly recommended that the anaesthetist should be appropriately trained and accredited, and directed and supervised by medically qualified specialist anaesthetist.
2. Professional Organizations
Anaesthetists should form appropriate organizations at local, regional, and national levels for the setting of standards of practice, supervision of training and continuing education with appropriate certification and accreditation, and general promotion of anaesthesia as an independent professional specialty. These organizations should form links with appropriate groups within the region or country and internationally.
3. Training, Certification and Accreditation
Adequate time and facilities should be available for professional training, both initial and continuing, to ensure that an adequate standard of knowledge, expertise, and practice is attained and maintained. Formal certification of training and accreditation to practice is recommended.
4. Records and Statistics
A record of the details and course of each anaesthetic should be made and preserved with the patients medical record. This should include details of the pre-operative assessment and the post-operative course. It is recommended that individuals, departments, and regional and national groups collect data to facilitate the progressive enhancement of the safety, efficiency, effectiveness, and appropriateness of anaesthesia.
5. Peer Review
Institutional, regional and/or national mechanisms to provide a continuing review of anaesthetic practice should be instituted. Regular confidential discussion of appropriate topics and cases with professional colleagues should take place. Mechanisms and protocols should be developed to ensure that deficiencies in individual and collective practice are identified and rectified. Anonymous incident reporting is encouraged as a useful mechanism in this respect. Legal safeguards of the confidentiality of the review material may be appropriate and should be sought where they do not already exist.
A sufficient number of trained anaesthetists should be available so that individuals may practice to a high standard. Time should be allocated for professional development, administration, research, and teaching.
An anaesthetist must be dedicated to each patient and be present throughout each anaesthetic (general, regional, or monitored sedation), and should be responsible for the ,transport of the patient to the post-anaesthesia recovery facility and the transfer of care to appropriately trained personnel. The anaesthetist should retain overall responsibility for the patient during the recovery period and should be readily available for consultation until the patient has made an adequate recovery. The anaesthetist should ensure, if aspects of direct care are delegated before, during, or after an anesthetic, that the person to whom responsibility is delegated is both suitably qualified and conversant with relevant information regarding the anaesthetic and the patient.
Where it is impossible for the above standard to be attained and the surgeon or another individual assumes responsibility for the anaesthetic, it is highly recommended that the practice and cases be reviewed and audited from time to time by an appropriately trained anaesthetist.
8. Facilities and Equipment
Appropriate equipment and facilities, adequate both in quantity and quality, should be present wherever anaesthesia and its recovery is undertaken. A list of recommended equipment and suggestions as to the order in which additions should be made as resources permit is given in Appendix B.
It is highly recommended that anaesthesia equipment conforms to relevant national and international standards.
Formal certification of an individual's ability to use a specific piece of equipment correctly and safely is encouraged.
PERI-ANAESTHETIC CARE AND MONITORING.
The first and most important component of peri-anaesthetic care, including monitoring of the anaesthesia delivery system and the patient, is the continuous presence of a vigilant anaesthetist throughout the operative period.
The patient must be evaluated by an anaesthetist prior to induction of anaesthesia. The anaesthetist must ensure that all necessary equipment is in working order prior to the induction of anaesthesia. The development of protocols to facilitate such verification is encouraged.
The anaesthetist should ensure that assistance is available and that the assistants has been instructed in, or is competent at, the necessary tasks.
MONITORING DURING ANAESTHESIA
(i) Oxygen supply : Supplemental oxygen is highly recommended for all patients undergoing general anaesthesia. The anaesthetist should ensure the integrity of the oxygen supply. When nitrous oxide or other supplemental gases are used, the concentration of oxygen in the inspired gas should be verified, at least at the commencement of each anaesthetic session. It is highly recommended that the inspired oxygen concentration be monitored throughout each anaesthetic with an instrument fitted with a low oxygen concentration alarm. An oxygen supply failure alarm and a device protecting against the delivery of an hypoxic gas mixture are highly recommended. A system should be used to prevent misconnection of gas sources.
(ii) Oxygenation of the Patient : Tissue oxygenation should be monitored whenever practicable by visual examination. Adequate illumination and exposure of the patient should be ensured whenever practicable unless an appropriate monitor is used. The continuous use of a quantitative monitor of oxygenation such as pulse oximeter is highly recommended.
B. Airway and Ventilation
* The adequacy of the airway and ventilation should be continuously monitored by observation and auscultation whenever practicable.
* Where a breathing circuit is used, movement of the reservoir bag should be observed. Continuous monitoring with a precordial, pretracheal, or oesophageal stethoscope is highly recommended.
* Confirmation of the correct placement of the endotracheal tube and the adequacy of ventilation by continuous measurement and display of the carbon dioxide waveform and concentration is highly recommended.
*When mechanical ventilation is employed, a 'disconnect alarm' should be used throughout the period of mechanical ventilation.
* Continuous measurement of the inspired and/or expired gas volumes is recommended.
(i) Cardiac rate and rhythm
* The circulation should be monitored continuously. Palpation or registration of the pulse and/or auscultation of the heart sounds should be continuous.
* Continuous monitoring and display of the heart rate with a plethysmograph (stand alone or pulse oximeter) or electrocardiograph are highly recommended. The provision of a defibrillator is highly recommended.
(ii) Tissue perfusion
* The adequacy of tissue perfusion should be monitored continually by clinical examination.
* Continuous monitoring with a plethysmograph or capnograph is highly recommended.
(iii) Blood pressure
* Arterial blood pressure should be determined at appropriate intervals (usually at least every five minutes, and more frequently if indicated by clinical circumstances).
* Continual registration of arterial pressure is encouraged in appropriate cases.
A means of measuring the temperature should be available and should be used at frequent intervals where clinically indicated (e.g. prolonged or complex anaesthetics, young children).
* The continual measurement of temperature in patients in whom a change is anticipated, intended or suspected is highly recommended. The provision and use of continuous electronic temperature measurement is recommended.
E. Depth of Anaesthesia
* The depth of anaesthesia should be regularly assessed by clinical means. The continuous measurement of inspired and expired concentrations of nitrous oxide and volatile agents is encouraged.
F. Neuromuscular Function
* When neuromuscular blocking drugs are given, the use of a peripheral nerve stimulator is recommended.
A. Facilities and Personnel
* All patients who have had an anaesthetic affecting central nervous system function and/or loss of protective reflexes should remain where anaesthetized or be transported to a location specifically designated for post-anaesthesia recovery. See 'General Standards" (Section 7) above for delegation of responsibilities of the anaesthetist.
* All patients should be observed and monitored in a manner appropriate to the state of their nervous system function, vital signs, and medical condition with emphasis on oxygenation, ventilation, and circulation.
* Supplementation of clinical monitoring with quantitative methods described above for intraanaesthetic patient care is recommended. Pulse oximetry is highly recommended.
Appendix A : GLOSSARY
1. "Anonymous incident reporting" mechanism for reporting anaesthesia incidents without identifying the individual administering the anaesthetic
2. "continual" repeated regularly and frequently
3. "continuous" without interruption
Appendix B : EQUIPMENT REQUIREMENTS
A. BASIC REQUIREMENTS
1. For anaesthetic administration as available, including intravenous anaesthesia, regional anaesthesia, and inhalational anaesthesia (open techniques or suitable draw-over vaporizer)
2. For patient monitoring
c. light source
3. For patient support
a. airway management (airways, masks suction apparatus laryngoscope, endotracheal tubes)
b. ventilatory support (self-inflating bag oxygen supply)
c. circulatory support (needles, syringes, cannulae, infusion fluid)
d. drug therapy (as appropriate for common emergencies and cardiopulmonary resuscitation)
B. INTERMEDIATE REQUIREMENTS (as above, PLUS)
1. For anaesthesia administration
a. compressed gas supply (02, N20)
b. calibrated vaporizer
c. anesthetic circuits
2. For patient monitoring
a. oxygen supply failure alarm
b. oxygen analyzer
d. capnometer e. ECG
3. For patient support defibrillator
C. OPTIMAL REQUIREMENTS ( as above, PLUS)
1. For anesthetic administration
a. anaesthesia machine with integrated monitoring of its function
b. neuromuscular blockers
2. For patient monitoring
a. of airway/ventilation (capnograph respiratory volume monitor airway pressure alarm)
b. of circulation (automated blood pressure (oscillometry) invasive hemodynamic pressures c. of administered anaesthetic peripheral nerve simulator respired drug monitoring)
3. For patient support
a. mechanical ventilator
* a disconnect alarm is mandatory if a mechanical ventilator is used (e.g. low pressure, capnograph, expired volume)
+ Members of the International Task Force on Anesthesia Safety
L.H.D.J. Booij (Netherlands), J.M. Desmonts (France),
P.G. Duncan (Canada), J.H. Eichhom (U.S.A.) secretary, J.S. Gravenstein
(U.S.A.), C.D. Hanning (U.K.), K. Ikeda (Japan), W.B. Runciman (Australia),
H. Stoeckel (Germany), T. Tammisto (Finland).
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by Ronald A. Gabel, M.D.
The New York State Society of Anesthesiologists is developing a model peer review program to fulfill state requirements for relicensure of physicians. It will involve centralized reporting of clinical quality assurance data about all anesthesiologists in the state.
In May 1986, Governor Mario Cuomo of New York State publicly announced his intention to require that physicians have their credentials periodically recertified in order to have their medical licenses renewed. This pronouncement was made approximately one year after Governor Cuomo signed a comprehensive medical malpractice reform bill designed to monitor and improve the quality of medical care provided to the citizens of New York State.(1,2,3)
Governor Cuomo requested that the Department of Health and the State Education Department appoint a committee to prepare recommendations for physician recredentialing. The report of that committee, the New York State Advisory Committee on Physician Recredentialing, was published in January 1988. It proposed that physician recredentialing be related to registration of medical licenses and that these processes take place every nine years. The Committee proposed that physicians who take care of patients in a hospital setting should have three options available for recredentialing: (1) specialty board certification or recertification; (2) cognitive and problem-solving examinations; and (3) peer review according to a specified protocol.(1,2,3)
The Committee stated in its 1988 report that the recredentialing process should not be punitive but should be directed toward education and remediation. Physicians judged to be practicing below given standards would be granted time-limited licenses to allow for remediation. If reassessment showed that deficiencies were not corrected within a reasonable length of time, the physician's license to practice medicine might be suspended until the deficiencies were corrected.(1,2,3)
In 1989 the Committee on Quality Assurance and Peer Review of the New York State Society of Anesthesiologists (NYSSA) began developing a model program of quality assurance and peer review to meet New York State's requirements for the recredentialing and relicensing of anesthesiologists. After the full committee met twice with NYSSA leadership to establish broad principles on which to base the model program, a subcommittee of NYSSA members began working out the details. Subcommittee members are Ronald A. Gabel, M.D. (Chair), Jared C. Barlow, M.D., John A. Gatell, M.D., Ingrid Hollinger, M.D., Marilyn A. Resurreccion, M.D., Albert J. Saubermann, M.D., Charles J. Vacanti, M.D., Mark D. Weibman, M.D., and Gerald L. Wolf, M.D.
To date (August 1992), the subcommittee has met for eight day-long sessions, six of them with Alfred Gellhorn, M.D., Director of Medical Affairs of the New York State Health Department and co-chair of the New York State Advisory Committee on Physician recredentialing. Through this process, NYSSA has developed a Model Program of Quality Assurance/Peer Review for Recredentialing/ Relicensure. This Model Program, which was approved by the NYSSA House of Delegates on December 8, 1991, is expected to meet the requirements of New York State for recredentialing and relicensing anesthesiologists according to a peer review process endorsed in the 1988 report of the New York State Advisory Committee on Physician Recredentialing. However, the Model Program is not yet fully developed, and the NYSSA Committee on Quality Assurance and Peer Review will continue working to complete and refine it. When approving the Model Program of Quality Assurance/Peer Review, the NYSSA House of Delegates specified that the Model Program was .accepted for implementation when all physicians are required to be recertified and relicensed by New York State, provided NYSSA plays a direct and active role in the implementation and administration of the Program.'
The overall philosophy on which the NYSSA Model Program is based is similar to that underlying the quality assurance program developed by Terry Vitez, M.D. (4) Physicians are human, and humans sometimes commit errors. ('To err is human.") A major goal of the NYSSA Model Program is to identify patterns of human error where they exist, enabling anesthesiologists to obtain remedial education or training when necessary. It is intended that this, in turn, will improve the quality of anesthesiology care provided to the citizens of New York State. The NYSSA Model Program is founded on the principle that the only appropriate method for identifying patterns of human error in anesthesiology practice is through peer review, a compassionate yet objective and rigorous assessment of performance by fellow anesthesiologists.
The NYSSA Model Program is essentially a standardized method of peer review. It includes procedures for case finding and for evaluating both process and outcome. The general approach taken is similar to that used in the quality assurance program developed by Dr. Vitez and endorsed by the American Society of Anesthesiologists (ASA) in 1989.(4) Additionally, the NYSSA Model Program requires anesthesiologists practicing in New York State to adhere to a rigorous set of clinical standards. Some of these standards are currently compulsory (New York State Health Code 405.135; others until now have been voluntary (three sets of clinical standards of the American Society of
The NYSSA Model Program is not meant to replace existing programs of quality assurance and peer review. Rather, it has been designed specifically to meet the requirements of New York State for recredentialing and relicensing anesthesiologists. Many departments of anesthesiology have well established quality assurance programs that may be more complete and more effective in assuring high quality anesthesia care than the NYSSA Model Program. NYSSA not only supports and endorses these efforts to maintain high standards of self-assessment, but takes the position that individual quality assurance programs should exceed the requirements of the NYSSA Model Program. This program has been developed because NYSSA recognizes that the State needs to adopt a standardized approach to peer review in order to recredential and relicense anesthesiologists.
The NYSSA Model Program has been standardized to permit development of a statewide anesthesiology clinical profile containing information on the performance of all anesthesiologists practicing in the State. The aggregate profile will include information on both process and outcome, as well as on compliance with standards. This statewide profile will be used as a standard for evaluating the performance profiles of individual anesthesiologists. Conventional statistical methods will be used to compare the clinical profiles of individual anesthesiologists with the statewide profile. This mechanism will be used for identification of outliers who may need remedial education or training (depending on their performance profiles) before being recredentialed in anesthesiology or relicensed to practice medicine in New York State.
It is not clear when the need will arise to apply the NYSSA Model Program to the recredentialing of anesthesiologists in New York State. This depends on the details of legislation implementing the recommendation of the Advisory Committee on Physician Recredentialing. A tort reform bill is currently before the New York State Legislature to provide financial compensation for impaired newborns as a substitute for parents' seeking damages for alleged malpractice. Tied to this bill is a requirement for obstetricians, pediatricians, and anesthesiologists to become recredentialed. The bill does not specify how this would be carried out if the legislation, as currently written, becomes law.
Most of the above article was extracted, with permission of the publisher, Little, Brown and Company, from: Gabel RA: Quality Assurance/Peer Review for Recredentialing/ Relicensure in New York State. International Anesthesiology Clinics 1992; 30:93-101.
Dr. Gabel, Professor of Anesthesiology at the University of Rochester, is Chairman of the Committee on Quality Assurance and Peer Review of the New York State Society of Anesthesiologists.
1 Gellhorn A, Cherkasky M. Report of the New York State Advisory Committee on physician recredentialing. Phase one: general principles, proposed process, recommendations. Albany, NY: Department of Health, State of New York, January 1988
2. Gellhorn A, Cherkasky M. Periodic physician recredendaling proposed in New York State. N Y State j Med. 1989;89:209-213
3. Gellhorn A. Periodic physician recredentialing. JAMA 1991;265:752-755
4. Vitez T: Judging clinical competence. Park Ridge, IL: American Society of Anesthesiologists, 1989
5. New York State Health Code. Part 405.13.1989
6. Standards for basic intra-operative monitoring. Directory of members. Park Ridge, IL: American Society of Anesthesiologists, 1991:67M71
7. Basic standards for pre-anesthesia care. Directory of members. Park Ridge, IL: American Society of Anesthesiologists, 1991:648
8. Standards for post-anesthesia care. Directory of members.
Park Ridge, IL: American Society of Anesthesiologists, 1991:672-673
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The Executive Committee at its February I meeting agreed to consolidate most of the APSF administrative functions, including fundraising, in a single independent office to be managed by an Executive Director of the APSF. The Executive Director will be assisted by an administrative assistant (part-time) and any other necessary office personnel. Fund-raising and most activities currently handled by the ASA Secretariat will be moved to the Executive Director's office.
Effective July 1, Dr. E. S. Siker assumed the position. The office is located in Pittsburgh.
Ellison C. Pierce, Jr., M.D. APSF President
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The Anesthesia Patient Safety Foundation Newsletter is the official publication of the nonprofit Anesthesia Patient Safety Foundation and is published quarterly 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, 1992
The opinions expressed in this newsletter are not necessarily those of the Anesthesia Patient Safety Foundation or its members or board of directors. Validity of opinions presented, drug dosages, accuracy and completeness of content are not guaranteed by the APSF.
APSF Executive Committee:
Ellison C. Pierce Jr., M.D., President; W. Dekle Rountree Jr., Vice-President; David M. Gaba, M.D., Secretary; Burton A. Dole, Jr., Treasurer; Casey D. Blitt, M.D.; Jeffrey B. Cooper, Ph.D.; Joachim S. Gravenstein, M.D.; E.S Siker, M.D.
Newsletter Editorial Board:
John H. Eichhom, M.D., Editor; David E. Lees, M.D. and Gerald L. Zeitlin, M.D., Associate Editors; Stanley J. Aukburg, M.D., Nancy Gondringer, C.R.N.A.; Jeffrey S. Vender, M. D., Ralph A. Epstein, M.D., Bernard V. Wetchler, M.D., Mr. Mark D. Wood.
Editorial Assistant. Nola Gibson
Address all general, membership, and subscription correspondence to:
Anesthesia Patient Safety Foundation
515 Busse Highway
Park Ridge, IL 60068
Address Newsletter editorial comments, questions, letters, and suggestions to:
John H. Eichhom, M.D. Editor, APSF Newsletter
Department of Anesthesiology
University of Mississippi Medical Center
2500 North State Street
Jackson, MS 39216-4505
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