ASA Standards Amended : C02 Seen After
Intubation Now the 'Standard of Care'
Substance Abuse in Anesthesia: Patient Safety Among Issues
Editorial: Impaired Providers Potential Danger to Patients, More to Selves
In My Opinion: Does Quality Assurance" Improve Safety?
In My Opinion: Vigilance Euphemistic or Veracious Motto
What is Role for QA
AANA Launches Quality and risk Management Initiative
Carbon Monoxide Gas May Be Linked to CO2 absorbent
Safety of Various Types of Anesthetics Tied to Risk Factors
Foreign Correspondence: Another "Wrong Gas" Incident in Hong Kong
Letters to the Editor:
by John H. Eichhorn, M.D.
Further "fine tuning" of the American Society of Anesthesiology published standards of care occurred at the ASA meeting in October. Previewed in the Fall 1990 issue of the APSF Newsletter were the proposed amendments to the Standards for Basic lntraoperative Monitoring and the Standards for Postanesthesia Cam These were adopted with minimal alteration and one comment.
An unplanned procedural development involved debate over the Standards for Conduction Anesthesia in Obstetrics. No consensus could be finally achieved regarding the many proposed alterations in those standards in time for consideration by the ASA House of Delegates. Therefore, the substance of this set of standards was left temporarily intact and the document was retitled "Guidelines" instead of "Standards" with the anticipation that a newly revised set of guidelines would be offered for approval in 1991. The Committee on Standards of Care and the Committee on Obstetric Anesthesia were charged with generating the new document and both are actively seeking input from all interested anesthesia providers. Specific analysis of the saw implications of these guidelines in their various forms will be forthcoming in a future Newsletter issue
The proposal to modify the intraoperative monitoring standards was adopted as offered and has direct relevance to patient safety. In the "Ventilation" section, the second point now reads: "When an endotracheal tube is inserted, its correct positioning in the trachea must be verified by clinical assessment and by identification of carbon dioxide in the expired gas. End-tidal C02 analysis, in use from the time of endotracheal tube placement, is encouraged."
Some Misplaced ET Tubes Stiff Going Unrecognized
This change was inspired by the fact that the ASA Closed Claims Study organizers have noted that unrecognized esophageal intubation was the single cause of anesthesia related catastrophe apparently least affected by all the patient safety efforts to date. The modification of the formal published standard (effective January 1, 199 1) stops short of mandating capnography in all cases when physically practical but a comment was generated in the ASA annual report that there was significant testimony at the Reference Committee that the Committee on Standards of Care should consider continuous end-tidal C02 monitoring as a future standard.
The pulse oximeter amendment to the standards for Postanesthesia Care was modified slightly in the review process and targeted to cover patients "in the initial phase of recovery" with mandatory pulse oximetry. Further, an exception was added with the wording "This is not intended for application during the recovery of the obstetrical patient in whom regional anesthesia was used for labor and vaginal delivery." The effective date is January 1, 1 992. At that time, it will be the formal published standard that, with the noted routine obstetrical exception, all patients who have received an anesthetic must be monitored at least in the initial phases of recovery with pulse oximetry.
Focus Shifted from OR
The impetus for the comparatively expansive scope of the PACU mandate was the recognition that in the last several years, there appeared to be far fewer intraoperative hypoxic incidents while, at the same time, hypoxic accidents in the PACU received much more attention, either because there were more of them or they simply stood out more as the OR accidents decreased dramatically The patient safety implications are clear. The drafters are hoping to optimize PACU outcome with pulse oximetry as one key component of a comprehensive safety program in a manner analogous to what many people believe has happened in the operating room. Also, in 1991, there likely will be an acceleration of the trend to equip PACUs with a significant, and therefore sufficient, number of pulse oximeters to meet this newly mandated level of care.
In the current year, in addition to the further work on the obstetrical guidelines, attention will be given via the ASA mechanism to the issues surrounding the JCAHO-required role for anesthesiologists to participate in the formulation of policy and procedure for non-anesthetists to use intravenous sedation outside the operating room. Again, the patient safety implications of such considerations are obvious and will be reported here as completed proposals are brought forth.
Dr. Eichhorn, of the University of Mississippi Medical Center is Editor of APSF Newsletter and a member of the ASA Committee on Standards of Care.
Back to Table of Contents
by Susan L. Polk, M.D.
The impaired anesthesia practitioner was the difficult topic addressed by a thoughtful, comprehensive workshop at the ASA Annual Meeting in October. The potentially very sensitive issue of patient safety implications of impaired anesthesia providers has been rarely addressed in the past.
This workshop, moderated by Dr. Philip Hanlon, Associate Professor of Anesthesiology at the University of South Alabama, began with a viewing of the newest ASA patient safety videotape, " The Impaired Practitioner: What Do We Do Now?" This videotape was produced by the U.S. Food and Drug Administration under the auspices of the ASA Committee on Patient Safety and Risk Management and the ASA Committee on Occupational Health. Distribution is being funded by the Burroughs Wellcome Co. it will soon be distributed to all departments of anesthesia in hospitals with more than 100 beds.
The video is introduced by Dr. Jim Arens, and consists of dialog with Drs. Clarence Ward and John Lecky punctuated by vignettes illustrating the identification of, intervention with, and successful reentry of an anesthesiologist (who is not a resident). Dr. Arens states at the outset that the tape is designed to prepare us for a problem that might crop up in the future, since when confronted with the problem of a colleague suspected of drug abuse, we often are not able to discover and learn the proper procedure in time to intervene effectively. The fact that chemical dependency is a disease is stressed throughout the tape. The endpoint of successful intervention and treatment should always be the safety and well-being of both the colleague and his patients.
Vignettes demonstrate common signals that a colleague is impaired by his substance abuse, such as change in personality, in personal habits and demeanor, and in family and community life. Work habits may become sloppy, but usually the actual performance of the impaired physician's job is the List aspect of his fife to deteriorate. The common ability to consume large doses of drugs and still perform his job lends the impaired anesthesiologist the feeling of being in control of his addiction.
Illustrations of a poorly executed and a property executed intervention were provided, with commentary indicating that intervention should never be attempted without planning, and never without the help of experts and family members. Intervention should stress concern for the well being of the anesthesiologist, his family, and his patients. Finally, intervention should be attempted only when solid arrangements have been finalized for the immediate entry of the anesthesiologist into an inpatient treatment program.
The components of a successful inpatient treatment program, generally taking at least 28 days, must include detoxification, a period of education to overcome the denial which is a hallmark symptom of addiction, and then behavior modification therapy to treat the disease, always including the physician's family in the process.
Reentry into anesthesia practice must be planned to provide for monitoring to assure the continued abstinence from all mood-altering drugs as well as the continued safety and well being of the recovering anesthesiologist and his patients. The video presentation emphasized the question of whether reentry is appropriate for anesthesiologists, quoting a successful recovery rate of 60-80'/o for the total population of all physicians but admitting that good data are not available for anesthesiologists returning to the proverbial "candy store". Questions cited at the end of the tape provided the grist for the rest of the workshop: What do you do when the recovered anesthesiologist suffers a relapse? When is a change of specialty in order? Who pays for treatment, recovery, and continued monitoring Is the recovering anesthesiologist able to obtain malpractice insurance? What is the liability of those who identify and intervene, as well as of the hospital and group, when the recovering anesthesiologist returns to practice?
What If You Are Mistaken?
Dr. Clarence E Ward addressed the risk of your liability should you attempt to intervene on a collegue when, in fact, he is not suffering from the disease of chemical dependency. It is not likely that you would come to this conclusion without irrefutable evidence, since it is the last diagnosis you would like to be making in your own colleague. It may be in some circumstances, though, that a secondary diagnosis such as a personality disorder might cloud your thinking about your colleague and allow you to operate with a feeling of malice. If you are certain that you have your colleagues and your patient's safety paramount in your mind, and if the intervention is carried out in a closed forum, it is quite unlikely that a defamation case could be supported. It is also quite unlikely that your collegue would risk publicizing the case by suing you. Your liability is much more likely to be due to not taking action when your collegue and his patients are in jeopardy because of his disease.
Is Reentry Appropriate For Residents?
Two department chairmen, Drs. Ronald Miller (UCSF) and Thomas Hornbein (University of Washington) were to have supported opposite sides of this issue, but neither was comfortable doing so because of the lack of data. Both cited the findings of Dr. Emil Menk, which in a survey of program directors discovered a successful re-entry rate of only 34% of residents who abused narcotics, contrasted with a 70% success rate when the drugs of choice were not narcotics. A "slip" is not a minor event to be forgiven in this population. Dr. Miller reported that of the four residents in his own program who were treated for narcotic dependency in the years 1970-82, only one is still living and practicing anesthesiology. Since iw, three more residents were identified, one of whom died before treatment and two of whom were treated in inpatient programs, such as the one described in the videotape. Of those, one leftanesthesiology after two relapses and one finished residency but was lost to follow-up. Citing his dismal success rate, Dr. Miller opined that perhaps residents who abuse opioids should be counseled into another specialty since they have not yet made a large investment in their careers, and since there is a growing body of evidence that many of these chose anesthesiology specifically because of drug aside Furthermore, the apparent fatality raw of a "slip," a relapse of opioid abuse, in the anesthesiology resident is 10-30%. Finally, residents who abuse opioids often do so while on call, and the impact on patient safety is too formidable to allow leniency about "slips." It may be possible to restrict practice to exclude availability of narcotics for a while after reentry, but graduation from residency cannot be allowed when practice has been restricted for long.
Dr. Hornbein agreed with Dr. Miller, citing the responsibility of program directors to certify their graduates as competent and of department heads to ensure the safety of all patients under the care of members of their departments. His personal experience includes 12 residents, and his policy in the past was that everyone " one chance to reenter but was not allowed to return if they had one relapse. More recently, Dr. Hornbein has used the continuation of denial on the part of the resident to indicate a high likelihood that reentry would meet with failure Admitting that there are no data as to whether outcome improves when recovering anesthesiologists return to another type of practice or when the anesthesiologist reports himself before his life and practice have seriously deteriorated, rather than requiring an external intervention, Dr. Hornbein leaned toward supporting the feeling that anesthesiology residents abusing opioids should not be allowed to resume their training in most cases. The Medical Society of New Jersey will no advocate for anesthesia residents in recovery to return to their programs, and will give practicing anesthesiologists only one chance at reentry into the specialty.
What Is Appropriate Treatment?
Dr. Neal Gray, an anesthesiologist practicing at the University of Tom at San Antonio and a certified Addictionologist, supported the opposite side of the question, citing his nine years experience with 600-700 chemically dependent physicians. He believes that anesthesiologists, even residents, can successfully reenter their field if & treatment and institutional policies covering reentry are appropriate for the disease. Over half of the physicians he has been involved with haw been in the top one-third of their classes and exceptional performers in their fields, and losing them from anesthesiology would unnecessarily shunt their talents, as well as, their problems off to another field.
Dr. Gray contrasted typical outpatient treatment by a psychiatrist to appropriate inpatient therapy. Outpatient psychiatric treatment might include replacement therapy rather than detoxification, psychotherapy to discover why the physician has become an addict rather than behavior modification, and aiming therapy to reduce the "causes" of addiction rather than treating the disease. Many psychiatrists do not require complete abstinence from all mood altering substances, but try to return the patient to "normal drinking." Appropriate inpatient therapy requires a full complement of physicians from many specialties to handle the detoxification stage which often includes several days of convulsions and ARDS. Other important characteristics were listed in the ASA videotape. Dr. Gray pointed out that Addictionologists generally agree that early alcoholics with a stable family and work environment and no other psychiatric diagnosis should be able to benefit from an outpatient program, as long as they are able to remain abstinent (but not one whose goal is to return the patient to "normal drinking").
All of the anesthesiologists that Dr. Gray has treated have returned to their work successfully, and he credits his reentry contract for this unprecedented success. It includes the following: Agreement to use no mood altering substances, participation in aftercare with regular (every evening and Saturday)AA or NA attendance, ordering of all medications (even for colds or headaches) by his personal physician, strict agreement on working hours, random observed urine or blood screening, naltrexone therapy for opioid abusers, and dismissal from employment for relapse. The drug screening must be random, and sample collection observed immediately after it is announced. The sample collector should be the same person at all times, and he should document the time and circumstances of collection, any other medications which the recovering physician has taken recently, and should hold all samples for a month in case any questions come up in the future. Reports of screens should be received by a designated supervising person. The recovering anesthesiologist must pay for the tests (around $150 for fentanyl currently) in this program.
Dr. Jim Arens, Chairman of the Department of Anesthesia at the Univenity of Texas at Galveston and Past President of the ASA, reported that the ASA will fund a prospective study, based at the University of Virginia. The study will track all anesthesia residents who enter substance abuse programs in order to determine whether their outcome depends on the type of treatment and rehabilitation program and the reentry contract. The ASA has also provided money for the development of an inexpensive, accurate, and sensitive screening test for fentanyl and its relatives, since these substances are currently not tested for in existing random drug screening program. The test, costing in the range of $12-$15, should be ready in two years, and members of the Society of Academic Anesthesia Chairmen (SAAC) will have it available for use then.
No one is willing to say that random testing will abolish this epidemic. The data cited by Dr. Arens suggest that random drug screening in the workplace might deter those who are entering anesthesia because of drug availability, might make drug users go to another institution for employment (as demonstrated in the few hospitals that have instituted such programs for all employees), and might be a deterrent for first time drug users (as has apparently occurred in NCAA athletic programs).
Who Flays For All Of This Treatment And Testing
Dr. Ward returned to provide depressing figures demonstrating the high cost and low level of support for the re-covering anesthesiologist. Treatment for the disease of chemical dependency is the fastest growing segment of health insurance currently. Inpatient programs with aftercare follow-up coast from $20,000 to $26,000, and most health insurance will cover only one 28-day inpatient course per lifetime. Many will not insure the recovering patient at all after that one inpatient course and treatment for a relapse is almost always paid out of the patient's own pocket. Disability coverage is notoriously poor after this diagnosis, and lost salaries for the treatment and rehabilitation periods are not insignificant. Most of the tine, the recovering physician has to pay for his own random screening tests. On the bright side, malpractice insurance seems not to have been affected at all by this diagnosis, perhaps reflecting that no publicly proven patient injury has ever been attributed directly to drug use by an anesthesiologist.
Dr. Polk, University of Chicago, is well known for educational
efforts within anesthesiology.
Back to Table of Contents
The panel in Las Vegas on "Substance Abuse among Anesthesiologists" focused primarily on the problem of abuse of fentanyl and its cogeners, and did not address such issues as alcoholism. Although narcotic addiction is a legitimate topic for the Anesthesia Patient Safety Foundation, there is no objectively documented evidence that anesthesiologists addicted to narcotics have harmed any patient. However, there is strong evidence that an addicted anesthesiologist is a safety hazard to himself.
Prevention of the problem is focusing on education of our specialty and upon developing of a simple, reliable, inexpensive test for the identification of fentanyl and its relatives in urine and/or blood. Once such a test becomes available, randomized drug screening will be seriously considered by this specialty.
A registry is also being developed to determine the incidence of recurrence once an addicted physician has undergone therapy. Hopefully, adequate information will be developed to provide insight into the current dilemma of whether an anesthesiologist, once addicted to fentanyl, should be allowed to re-enter the specialty.
Thus, at present the addicted anesthesiologist could potentially be a hazard to patient safety. The primary safety hazard today for such an addicted physician is to the addict and not the patient. The most frightening aspect is frequently the hazard is not re-addiction, but rather death of the afflicted anesthesiologist.
The ASA patient safety videotape, "The Impaired Practitioner," is available from Burroughs-Wellcome representatives.
James E Arens, M.D. Past President, ASA
Back to Table of Contents
From time to time and starting with the piece below, the APSF Newsletter will feature a new column - In my opinionů
"In My Opinion. . ." is not meant to be an official APSF editorial, but rather an opportunity for invited respondents to address interesting and controversial issues. These issues should not be geographically or institutionally unique and are meant to represent areas of broad interest and concern. The focus is to create discussions in response to thought-provoking questions. Example topics will include: "Should the surgeon be present in the OR for induction;" "Conscious sedation in the GI lab Anesthesiology roles and responsibilities."
Newsletter readers are invited to submit questions they would like addressed, or answers to (opinions on) questions they have institutionally (or individually) dealt with.
Jeffrey S. Vender, M.D.
Back to Table of Contents
by David W Edsall, M.D.
Editor's Note: As stated on above, "In My Opinion . . " is not an APSF Editorial, but rather an opportunity for invited respondents to address interesting and controversial issues.
Vigilance is the motto of the ASA and the AANA. Is it important? Our emblem and most individuals say "Yes". However, our textbooks imply "no." A review of fourteen textbooks on display at the 1990 ASA Exhibits showed twelve without the word "vigilance" in the index. These textbooks covered the areas of pediatric, obstetric, intensive care, cardiovascular, and introductory reference anesthesia. Miller's text, considered by many to be the best text available, makes only a brief statement about vigilance in context with anesthesia for the elderly. One British text has somewhat more than passing remarks, but that statement is less than a page in length.
A review of the anesthesiology literature also can lead to the conclusion that vigilance is not considered important. In six hours at a university library, only three editorials (1,2,3) and three original scientific paper (4,5,6) on vigilance in anesthesiology from all of the 1980s could be found. Two papers dealt with the effects of fatigue on vigilance. (4,5) The other one dealt with the effect of automation on vigilance. 6 Of the 1,273 abstracts presented at the 1990 ASA one purports to address the subject of vigilanM7 To an untrained em more than one of the above authors appear not to understand what vigilance is.
What is vigilance? No one in an average-sized community hospital department could come up with a good definition. No one in & audience at three different prestigious anesthesia programs could give either a dictionary or descriptive definition of vigilance. During the same library search, literally thousands of articles on vigilance published since World War II were found. Dozens of articles from the last five years seem to be relevant to the aspects of vigilance which might apply to anesthesiology. Several textbooks about vigilance are available. (8,9) Vigilance has been researched in workers with multiple various tasks including: food and industry inspectors, truck drivers, subway operators, nuclear power plant operators, air traffic controllers, pilots, submarine sonar operators, and multiple other task scenarios, but not anesthesia providers.
Vigilance is sustained attention. Attention toward what? What aspect of the anesthesia cockpit are we to keep our attention sustained toward the operative field, the monitors, the patient's pupils, the I.V. drip rate, or the blood loss? How can we sustain our attention toward all these things at the same time? In fact, vigilance literature specifically states that we should be vigilant toward any signal which indicates a potential injury to the system which me human beings are monitoring. Vigilance is sustained attention, watching for a signal to which one should respond. The objective measure of vigilance and its effectiveness is the response time to that signal. Research on vigilance deals with the environmental, human, and signal characteristics which affect the response rate to that signal.
Characteristics intrinsic to the vigilance paradigm are:
1 . The task must be prolonged and continuous.
2 . The signals to be detected are highly discriminable to the alert observer.
3 . The signals are infrequent and aperiodic.
4. The human's response has no effect on the signal rate
Initially, this may also sound confusing until one realizes that a signal is different from an event. An example of an event is an unchanged blood pressure recording of 1 30/80. An example of a signal is a new, sudden blood pressure recording of 70/55. A signal is an event to which @Km should respond. Since we are not supposed to respond to a normal and unchanging blood pressure, vigilance toward that event (absence of change) is at best inconsequential, and at worst harmful. Likewise, are we to be vigilant toward the intentional clamping of an esophageal stethoscope, or toward an event which can injure the patient, such as the disconnection of an endotracheal tube? The former will not injure the patient by itself, and may not even change our detection of the latter signal, depending on our other monitoring techniques.
Fatigue certainly plays a role in vigilance, and yet it is only one of more than thirty factors which have been clearly shown to affect vigilance tasks. What are the effects of things such as: background event rate, caffeine, propranolol, smoking, false alarm rate, length of case, and number of cases per day on vigilance in anesthesiology? As the event rate (i.e. number of vital signs per hour) increases, and the signal rate decreases (as implied through apparent increased safety in anesthesiology), we appear to be heading toward a scenario in which human vigilance can be severely negatively impacted. At what level of monitoring does the anesthetist hit his or her "biological barrier" where the mind becomes confused by processing too much data and the speed and accuracy with which one responds to a signal decreases?
Anesthesiologists should be students of the science of vigilance. We should apply that knowledge to research in concerning anesthesia tasks. It is possible we have not done this because we have not had the tools. It is believed that the automated anesthesia record may serve as one of those tools. Mackie states that "vigilance is extraordinarily time dependent, as the four aspects of the vigilance paradigm demonstrates" (11) A computer can be used as a time monitor of the chronology of events in the operating room. Therefore, response times can be studied. Once this tool is developed, possibly we can determine the effect of circadian rhythms and other often-cited factors on Vigilance in clinical anesthesia practice.
Other types of tasks that have been studied appear to show that over-automation can lead to boredom resulting in decreased vigilance with the "human-computer", team. (12,8) However, correct application of the human-computer team in the task involved can dramatically improve Vigilance. For instance, humans are notoriously poor with negative signals, whereas computers are relatively good at detecting negative signals. Humans are good at prioritizing signals, computers are relatively poor. As automated records and servo-control mechanisms linked to end-tidal carbon dioxide, agent concentration, and blood pressure gain acceptance, the issue of human-computer interactive performance becomes more important.
It can be argued that complex multioriented tasks do not have a vigilance decrement. (13) If that is the case in anesthesiology, then addressing the above questions will demonstrate that vigilance is not a real issue in our profession. Should we not then change our oft-quoted motto?
If "vigilance" in anesthesiology is only a euphemism, lets change our motto. If it is a valid concept, let's apply it to our daily education and practice
Dr. Edsall is Chairman, Department of Anesthesiology, Burbank Hospital, Fitchburg, MA.
1. A matter of vigilance(Editorial). Anesthesia 41:129-130, 1986.
2. Minimal monitoring and vigilance (Editorial). Anesthesia 42:683-684,1987.
3. Why investigate vigilance? (Editorial). J Clin Monit 2(3): 145-147, 1986.
4. Denisco RA, Drummond JN, Gravenstein JS: The effect of fatigue on the performance of a simulated anesthetic monitoring task. I Clin Monit 3(l): 22-24, 1987.
5. Paget NS, Lambert TF, Sridhark K. Factors affecting an anesthetist's work: Some findings on vigilance and performance Anaesth intens care 9:359, 1981.
6. Kay 1, Ned M: Effect of automatic blood pressure devices on vigilance of anesthesia residents. J Clin Monit 2(3): 148-150,1986.
7. Yablok, DO: Comparison of vigilance using automated versus handwritten records. Anesthesiology 73 (3A): A416, 1990.
8. Warm, IS (ed): Sustained attention in human performance The Wiley Series on Studies in Human Performance. Volume 4.
9. Wiener, EL(ed): Human Factors in Aviation. Harcourt Brace Jovanovich, Publishers.
10. Percival LC, Noonan TK: Computer network operation: Applicability of the vigilance paradigm to key tasks. Human Factors 29(6): 685-694, 1987.
11. Mackie RR: Vigilance research are we ready for counter-measures? Human Factors 29 (6): 707-723, 1987.
12. Parasuraman R: Human-computer monitoring. Human Factors 2 9(6): 695-706, 198 7.
13. Wiener EL: Application of vigilance research: Rare medium or well done? Human Factors 29 (6): 725-736, 1987.
Back to Table of Contents
by Gerald L. Zeitlin, M.D.
Do Quality Assurance programs make anesthesia safer? There is little direct evidence on which to base an answer only intuition and opinion. Academic and community anesthesia practitioners were recently surveyed about their attitudes toward such program. (Chapman GM M.D., personal communication, December 1990). Their comments ranged from, "have been extremely pleased with the program to date" to "...Q.A. a big game... quality of anesthesia not improvedů does not get inside the head of a practicing anesthesiologist." In between these extremes, there was a broad spectrum of opinion. Such opinions must be taken seriously before the anesthesia community uncritically adopts one or another specific Quality Assurance (QA) program.
An analysis of QA programs requires two assumptions: first, that any mechanism intended to assure better quality of anesthesia care at least includes the aim of improving patient safety and, second, that all anesthesiologists welcome objective information about their own performance so they can try to improve the care they give.
An examination of three well-known QA programs may reveal whether they are likely to help or hinder anesthesiologists in these endeavors. In Table I the philosophy behind each program and the methods used are classified. All three programs either state or imply that their aim is to make unbiased assessments of competence.
The incentive for developing these formal and, in some cases, commercially available programs, presumably is the following statement in the JCAHO Manual on Monitors of quality and Appropriateness of Patient Care: "The following screening criteria will be utilized to identify possible variations for review". There after is a list of adverse outcomes such as cardiac arrest, peri-operative myocardial infarction, variations of blood pressure beyond certain ordained limits, etc.
Does the word "variations" mean mathematical demonstration of a number of adverse events beyond a predetermined acceptable frequency? It appears that the authors of these QA programs mistakenly concluded just that from the coincidence of three factors: fast, the belief that the nature of anesthetic practice is such that high quality is associated only with absence or decrease in number of adverse events; second, the looming demand from various authorities for recredentialling seems to require placing a numerical value on an anesthesiologists competence; third, the belief that norms of competence can be established for groups of anesthesiologists. Surgeons and patients constantly place new challenges before us. When it is assumed that a particular rate of adverse outcomes is the acceptable one, it is like trying to measure the height of a sand dune in the middle of a blizzard. Two recent examples of these challenges involve the complexities of taking care of patients having insertion of automatic implantable cardioverter defibrillators and the difficulties associated with anesthetizing young children undergoing scans in the highly magnetic environment of the MRI machine.
Summary of Three Quality Assurance Programs
Philosophy: Determining clinical competence involves decisions made by fallible humans and the best competence indicator is outcome
Method: Depends on outcome analysis which must be continual and collective, conditional, (i.e. under circumstances of usual practice), compared with peers, and include established minimal acceptable levels of performance.
Evaluation: Individual negative outcome scores compared to those of "competent" members of department.
Philosophy: Evaluate by absence of adverse patient occurrences.
Method: Evaluate adverse occurrences as "avoidable" and "unavoidable". Care in avoidable cases divided into appropriate and inappropriate. Evaluation: Each department must set its own criteria. Revise QA program periodically.
Philosophy: Plan corrective action for practitioners with higher complication rates.
Method: Collect annual number of adverse incidents for the practitioner.
Evaluation: Compare to departmental mean.
Types of Programs
Do these types of QA programs justify their use of mathematical comparisons of incident rates?
Program A describes minimal performance levels for practitioners who are expected to anesthetize healthy patients without permanent damage, institute appropriate life-sustaining actions in life-threatening situations and, lastly, display insight when involved in an important error. It is impossible to quarrel with these guidelines, but diem are uncertainties about the validity of placing a numerical score on breaches of these guidelines. Even though cases are reviewed anonymously by a member of the departmental QA Committee, bias seems inevitable. Caplan et all, using cases drawn from the ASA closed claims database, showed that a large group of peer reviewers exhibited biases in a situation analogous to
Program A. They demonstrated an association between rendering judgements that care was inappropriate and the fact that the patients' injuries were permanent and more severe By presenting identical case scenarios to the reviewers with alternating plausible but opposite outcomes, they demonstrated that the judgements were independent of the details of the cases.
Program B is much less certain as to whether competence can be enumerated. This uncertainty is illustrated by the following statements: "if the practice profiles of the providers consistently meet established standards, then it is likely the standards are set too law," and later, "the acceptable rate for various adverse patient occurrences is not universally agreed upon!" However, it still leans heavily on the concept of counting adverse outcomes.
Program C boldly generates the incidence of critical events per 1000 anesthetics per physician and compares this with the departmental mean value. It emphasizes that such numbers are likely to be accepted by Government agencies that might establish a recredentialling process. This is a simplistic response to a bureaucratic demand. It is quite possible that more conscientious anesthesiologists do more difficult cases and voluntarily report more adverse outcomes (which could lead to their being sanctioned under this system).
All three programs invoke the use of widely accepted "standards of care" to support their methods and imply that the proposed QA mechanisms will lead to measureable improvement in anesthesia outcomes. The link to standards of cam seems somewhat tenuous. An example from the ASA Closed Claims Study is relevant. The ASA Closed Claims database contains 168 cases drawn from the files of the Massachusetts Joint Underwriters Association (JUA) which was established in 1975 and has consistently insured an average of 350 anesthesiologists. On July 1, 1987 all anesthesiologists insured by the JUA became eligible for a 20% "risk management" discount in their malpractice insurance premium if they signed a document agreeing to abide by the ASA Monitoring Standards and use pulse oximetry and capnography wherever applicable and also to submit to random audit on these points. Between 1975 and December 1984, there were 49 deaths which led to malpractice
Claims against JUA insured anesthesiology (2). Since the wide spread application of the discount on July 1, 1987, there has been no JUA suits brought for death associated with anesthesia in which practitioners were observing the rules of the risk management agreement. Nor were there any such deaths reported to the JUA occurring between January 1, 1985 and July 1987. To suggest similar results from a proposed QA program requires essentially "leap of faith" assumptions.
Anesthesia Hard to Study
Quality assurance activity in anesthesia is inherently more difficult than in other specialties in which studies of outcome are derived from controlled comparisons between alternative therapies. The study by Roos et al (3) comparing mortality and reoperation rates after transurethral and open prostatectomy is a good example. Since anesthesia per se is almost always non-therapeutic, its outcome can only be quantified in one way -fewer adverse outcomes. If I were to have no pneumothoraces following central venous catheterization for ten years (not true), does this prove that my technique and selection of patients for this procedure is period? I do not know. But I do know that since my patients have suffered this complication twice, I am more cautious than ever. If my colleague has caused three pneumothoraces in the same time period, this gives me no comfort as to the possibility that my technique is better.
Can this objection be overcome by pooling of data to compensate for the low frequency of adverse outcomes? This would require all anesthesiologists in a vast number of hospitals to practice in only one way, in comparable environments, with equally sick patients, working with measurably equally competent surgeons, and they submit themselves to a single peer review mechanism. These difficulties can be profitably compared to those experienced by the Health Care Financing Administration since 1986 while trying to use hospital mortality data as an adequate measure of quality of care'. Neither adjustment for length of follow-up nor severity of illness has yet been able to produce comparisons between hospitals that are valid or worth anything at all.
Feedback from Data
These criticisms of anesthesia QA programs do not deny that they may have other uses. One can learn from them. Few anesthesiologists have the time to record all the outcomes for all their patients, so data storage through a QA mechanism assists s&-analysis. This is the "feedback" benefit of data collection. Good large-scale examples of this are the Maternal Death Reports from the United Kingdom (5) which led to a substantial changeover from general to regional anesthesia in obstetrics and the New South Wales Mortality data (6) which contributed to a 5-fold decrease in anesthesia associated mortality between 1960 and 1987. A more specific study of the effect of instituting a QA program by Schreider et al (7) also suggests that feedback from QA may well contribute to improved care.
In all the welter of discussion about quality assurance, pea review, standards of cam, and practice parameters, one rarely heard the word "conscience" applied to the care of patients in the operating room. That is, until Rhoton et al (8) published their study of the behavior of anesthesia residents, which strongly suggested that conscientiousness (among other non-cognitive variables) was a powerful predictor of overall performance assessments and its absence played a crucial role as a predictor of critical incidents. The anonymous responder in the survey described above said functionally the same thing: "QA programs ... do not get into the head of the practicing anesthesiologist."
Suppose a quality assurance program demonstrates to an anesthesiologist that his patients have an unusually large number of perioperative M.I.'s. If one assumes that our criteria for selecting residents for anesthesia training are adequate, that review of training programs appropriately strict, and that the supervision and teaching of residents is conscientious, then this anesthesiologist will turn to Mangano's article on Perioperative Cardiac Morbidity (PCM) (9) and will discover that some predictors of PCM have been clearly identified and others are suspected and he will adjust his thinking and practice accordingly. He does not need a QA committee to tell him to do this. If the reader considers this scenario naive, then he or she does not have an ideal view of the role of the anesthesiologist as physician.
Can others who are interested in the quality of care in medicine help answer these questions? Eddy (10) in a series of articles on clinical decision making says the assumption that all physicians' decisions are correct is being increasingly challenged and that this challenge is justified by a concern for quality. He asks whether pre-guessing or second-guessing each physician's decisions can be counted on to make the ultimate choice commit? He answers that, while these mechanisms are well-intentioned, while they are steps in the right direction, and while they may the best we can do right now, they will by no means prevent or correct every error. There are three main problem. First, who can say that a guideline developed by an expert panel is correct? Second, many medical decisions are inherently too subtle be made at a distance(eg. my colleagues rarely have time to watch me insert central venous catheters). Third, even if these quality assurance mechanisms worked in the sense of "correcting" incorrect decisions over the long haul, they are cumbersome, expensive, and potentially demoralizing for physicians.
Group Not Always Right
Most telling of all, Eddy states these mechanisms depend on a Questionable assumption. Virtually all current quality assurance mechanisms assume there is 11 accuracy in numbers". In other words, if the decisions of individual physicians cannot be busted, can the collective decision of a large number of physicians be trusted? He concludes that the solution is not to remove the decision-making power from physicians through extreme imposition of substituted judgments, but to approve the capacity of physicians to make better decisions.
In the article "Continuous Improvement as an ideal in Health Care", Berwick says it best: "We are wasting our time with the Theory of Bad Apples and our defensive response to it in health care today, and we can best begin by freeing ourselves from the fear, accusation, defensiveness and naivete of an empty search for improvement through inspection and discipline."
Can QA programs improve patient safety? Yes; but only if they are used to give the individual practitioner concrete information about how to improve his own specific practice.
Dr. Zeitlin is a Senior Staff Anesthesiologist at the Lahey Clinic in Burlington, MA and an Associate Editor of the APSF Newsletter.
1. Caplan RA, Posner K, Cheney FW. Effect of outcome on physicians' judgments of appropriateness of care. Anesthesiol 1990;73:AI247
2. Zeitlin GL. The Massachusetts anesthetic malpractice experience: Comparison with the American Society of Anesthesiologist Closed Claims Study. Poster presentation at 8th European Congress of Anesthesiology, Warsaw, Sept. 1990
3. Roos NP, Wennberg JE, Malenka DJ. Mortality and reoperation after open and transurethral resection of the prostate for benign prostatic hypertrophy. N. Engl. J. Med. 1989; 320:1120-1124
4. Green J. Wintfield N, Sharkey P, Passman LJ. The Importance of severity of illness in assessing hospital mortality. 1990; 263: 241-246
5. Morgan M. Anesthetic contribution to maternal mortality. Brit J Anesth. 1987; 59; 842-855
6. Holland R. Anesthetic mortality in New South Wales. Brit. J Anaesth. 1987; 59: 834-841
7. Schreider B, Roizen MF, Lichtor L, Roberts R, Keany M, Polk S, Delisi M, Holmes R. Does a quality assurance program improve patient care? Anesthesiol. 1988;693A:A499
8. Rhoton W, Barnes A, Flashburg M, Ronai A, Springman S. Noncognitive variables: primary determinants of clinical performance and precursors of critical incidents in five anesthesiology training programs. Anesthesiol. 1990; 73: A1056
9. Mangano DT Perioperative Cardiac Morbidity Anesthesiol. 1990; 72: 153-184
10. Eddy DM. Clinical Decision Making: From Theory to Practice The Challenge. JAMA. 1990; 263: 287-290
11. Berwick DM. Continuous improvement as an ideal in
health cam N. Engl. J. Med. 1990; 320: 53-56
Back to Table of Contents
by Nancy Gondringer, C.R.N.A.
The American Association of Nurse Anesthetists has launched an initiative in risk and quality management with the establishment of "Anesthesia Quality Plus," the quality assurance and risk management division of Anesthesia Professional Liability Services, Inc., AANA's insurance subsidiary Anesthesia Quality Plus has three major missions: education, research, and service.
The education mission will be achieved primarily by sponsoring workshops and seminars on topics in risk management, quality assurance, anesthesia law, and patient safety. AQ+ also publishes a bimonthly newsletter sent to all AANA members free of charge, as well as other related material from time to time. AQ+ sponsored its first workshop on March 8-10, 1991, at the Aladdin Hotel in Las Vegas, Nevada. The workshop was called "Anesthesia Quality Management and Marketing," and focused on preparing an anesthesia department for a Joint Commission survey and how to market anesthesia services by emphasizing the quality aspects of cam Jonathan T. Lord, M.D., an experienced surveyor and consultant to the JCAHO taught the QA portion and Professor Kenneth Bopp taught the marketing portion of the meeting. Anesthesia risks and their prevention were also presented by the Director of AQ+, Gary Kraus, M.B,A., JD.
Research activities sponsored by AQ+ will be in the nature of closed claims studies and quality assurance and continuous quality monitoring in anesthesia. Currently, AQ+ is working with the faculty of the Department of Health Services Management at the University of Missouri-Columbia on testing quality indicators.
The service component of AQ+ consists of the establishment of three bureaus, one each in speaking, consulting, and expert witnesses and the development of a "Continuous Quality Improvement Management and Information System" for an anesthesia department or group practice. The services bureaus will go on-line in the Spring and the information and management system is scheduled to be ready during the Summer of 199 1. Individuals or organizations who need the services of either a consultant, speaker, or expert witness can contact AQ+ and they will be provided with the names of persons qualified and willing to perform the specific service.
The information and management system is described as a state-of-the-art automated program that meets or exceeds JCAHO and other agencies requirements for continuous quality improvement, quality assurance, and peer review, at an affordable price. The system will be available for institution department quality assurance activities and the user can also opt to compare the quality of their practices at the local, state or national level by participating in a confidential data base.
Individuals interested in any of the programs of Anesthesia Quality Plus can contact Mr. Kraus at 216 Higgins Road, Park Ridge, Illinois 60068.
Ms. Gondringer, Lincoln, Nebraska, is an APSF Director
and a member of the Newsletter Editorial Board.
Back to Table of Contents
by Richard Moon, M.D.
Twenty-eight instances of unexplained elevation of blood carboxyhemoglobin (COHb) have occurred in three institutions. Al Grady Hospital, Atlanta, GA, 16 cases occurred between May 1985 and March 1990. At Duke University Medical Center, Durham, NC, eight cases occurred from January to October 1990. At Northwestern Memorial Hospital, Chicago, IL, there were three cases observed from July to September 1990. In 8 of 28, cases peak COHb has been 2 8% or greater. In three instances, COHb level has been 30%. Although 12 of the 28 patients were smokers, there was no reason to suspect preoperative CO poisoning in any of the patients, and, in fact, a documented rise in COHb occurred in 12 cases. To date, no severe patient complications have occurred, although COHb levels have been observed that could conceivably contribute to patient morbidity or mortality in some patients. Them were no hemodynamic or other changes suggestive of a problem.
At least 27 of the 28 patients with CO poisoning were the first to be anesthetized after a period of at least 2 4 hours of nonuse of the anesthesia machine (usually a weekend). Carbon monoxide gas has been detected within the C02 absorbent canisters. Preliminary evidence suggests that carbon monoxide accumulation may occur as a result of a slow chemical reaction between one or more fluorinated anesthetics and some C02 absorbents.
These documented abnormalities were detected serendipitously because routine co-oximetry is performed on arterial blood samples in the three institutions. It must be emphasized that neither routine arterial blood gas analysis nor pulse oximetry will provide specific evidence of carbon monoxide poisoning.
The causes of this problem have not been fully defined. Possible procedures for attempting to minimize the risk of CO poisoning have included:
1. Flushing resident gas from the C02 absorbent canisters prior to each anesthetic by using a high flow of oxygen for at least sixty seconds.
2. Use of high fresh gas flows (greater than or equal to five liters per minute) during the course of the anesthetic. Low flows especially should be avoided.
3. Insertion of new C02 absorbent canisters after any period of disuse greater than 24 hours.
We suggest that initial treatment of any patient with elevated CO2 include increasing the inspired 02 concentration to 100%, using high fresh gas flow, and other replacing the C02 absorbers with fresh material or switching to a non-rebreathing circuit.
Any cases observed can be reported to Richard Moon, M.D.
(Department of Anesthesiology, Box 3094, Duke University Medical Center,
Durham, NC 27710), Charles Ingram, M.D. (Department of Anesthesiology,
Thomas K. Glenn Memorial Building, 69 Butler Street, SE, Emory University
School of Medicine, Atlanta, GA 30303), or Edward Brunner, M.D., Ph.D,(Professor
and Chairman, Department of Anesthesia, Northwestern University Medical
Center, 303 E. Superior Street, Chicago, IL 60611).
Back to Table of Contents
Large Multi-Center Trial Evaluates Drugs, Adverse Outcomes
by James B. Forrest, M.D., Ph.D.
Potential risk factors for adverse outcomes of general anesthesia include, among others, the health status of the patient, the type of surgery, and the anesthetic drugs used. Unfortunately, very few studies have examined these risk factors in sufficient detail to assist the anesthesiologist in everyday practice. In our large study, we hoped originally to test two hypotheses. (1) that there are no significant differences in the risks of death, myocardial infarction, and stroke with the use of enflurane, fentanyl, halothane, or isoflurane, and (2) that there are differences for other adverse outcomes, such as arrhythmias, hypotension, or vomiting with these four anesthetics. To test the first hypothesis would require 230,000 patients to be studied and we therefore decided to focus on the second hypothesis.
A prospective randomized clinical trial of these four anesthetics was done involving 17,201 patients in 15 university teaching hospitals in the United States and Canada. (1) Adult patients were studied before, during and up to seven days after general anesthesia with 66 types of adverse outcomes recorded. In this study most patients were healthy (90.7%) but there were 1,607 patients ASA Physical Status 3 or 4. The most common types of surgery were musculoskeletal, abdominal and gynecologic and about two thirds of the patients were female. Nineteen patients in the study died and in seven of these, the anesthetic may have been a contributing factor. (2)
The rates of 16 of 66 types of adverse outcomes differed among the four study anesthetics. Thus atrial, nodal, and ventricular arrhythmias were more common with halothane; tachycardia was more common with isoflurane; bradycardia and hypertension were more common and hypotension less common with fentanyl. Cough, laryngospasm, and secretions were equity common with the three volatile anesthetics whereas bronchospasm was more common with fentanyl. Postanesthetic nausea and vomiting were more common but shivering was less common with fentanyl. Most of these adverse outcomes were minor but severe ventricular arrhythmia was more common with halothane, severe hypertension and bronchospasm were more common with fentanyl, and severe tachycardia was more common with isoflurane.
Risk Factors Studied
The next stage of our analysis was a detailed computation of the risks and predictors of severe perioperative adverse outcomes in the 17,201 patients in the study.' One hundred potential risk factors, such as preoperative diseases, surgical procedures, age, gender, obesity, smoking status, ASA Physical Status and the four study anesthetics were tested for each of the 66 types of severe perioperative outcomes. lndependentpixActorsforsevewcardiovascularoutcomesincludedpreoperativecardiovasculardisease, cardiothoracic surgery, ASA Physical Status 3 or 4, age over 60 years as well as the study anesthetics. We found most predictors confirmed the overall clinical experience of the practicing anesthesiologist. However, some were less important than expected, for example preoperative diabetes, COPD, or asthma carried only relatively small risks of severe perioperative outcomes.
The clinical implications of the Multicenter Study of General Anesthesia relate to the prediction of the risks of a wide range of severe perioperative adverse outcomes which can be computed for an individual patient. This provides the anesthesiologist with a guide to the appropriate selection of the anesthetic as well as highlights those preoperative conditions and types of surgery that have the potential for serious risk for that patient.
Dr. Forrest, McMaster University, Hamilton, Ontario, is organizer and lead author of the comparison studies of different anesthetics.
1. Forrest JB, Rehder K, Goldsmith CH, Cahalan MK, et al: Multicenter Study of General Anesthesia. I. Design and Patient Demography. Anesthesiology. 72:252-261,1990.
2. Forrest JB, Cahalan MK, Rehder K, Goldsmith CH, et a]: Multicenter Study of General Anesthesia. 11. Results. Anesthesiology 72:262-268, 1990.
3. Forrest JB, Rehder K, Cahalan MK, Goldsmith CH: Multicenter
Study of General Anesthesia. Ill. Predictors of Severe Perioperative Adverse
Outcomes (submitted for publication).
Back to Table of Contents
by Professor Ross Holland
Case 1: On 2lst July, 1990 (a Saturday afternoon), a patient at Caritas Hospital, Hong Kong, underwent emergency Caesarean section. The operation took place in an operating room which is separate from the main suite, and is used for emergency only. It does not have bulk gas supply pipelines.
The unpremedicated patient was pre-oxygenated via a Magill breathing circuit, given thiopentone and suxamethonium in appropriate doses, and intubated. A 50% mixture of nitrous oxide and oxygen with 0.5% halothane was given via a Manley MP3 ventilator with a fresh gas flow of 6L/minute. Monitoring was by means of an oximeter, a non-invasive blood pressure recorder, and an EKG. No oxygen analyzer or capnograph was in use
When the suxamethonium had worn off, alcuronium was given, and the baby was delivered in good condition shortly after. Up to this time, the anaesthesia had been uneventful, but a bradycardia then developed, followed by severe hypotension. At one stage, cardiac arrest appeared, but a detached EKG electrode was replaced, with return of the trace to the screen.
Halothane was discontinued and the pulse rose, although the patient remained hypotensive. A few ventricular premature beats were noted. The operation was rapidly completed and the patient reversed. She breathed satisfactorily, but did not wake up, and she was therefore sent to Intensive Care where her saturation was noted to be 92-93% despite an FI02 of 0.4. A blood gas estimation revealed a pH of 7.106 and PaCO2 Of 51 mmHg.
One hour later, she recovered consciousness, and appeared well. The baby made satisfactory progress.
Pattern of N20 Problems
Case 2: On the following day (a Sunday), another woman was also given general anaesthesia in the same operating room for Caesarean section, utilizing an identical technique to Case 1. In this patient, tachycardia, and hypertension (I 60/120) developed within minutes of induction, together with a few ventricular ectopics. FiO2 was increased to 1.0, and the baby delivered with an Apgar of 6, rising to 9 at five minutes. Nitrous oxide was reintroduced, and tachycardia and hypertension reappeared.
At the conclusion of the operation 20 minutes later, the patient was grossly agitated and confused. She was given diazepam 5 mgm IV and temporarily settled, but 30 minutes later was again uncontrollable. Since she had been given 15 mg of alcuronium less than 20 minutes before reversal , a consultant who was called at this time thought she may have been inadequately reversed, but a further dose of neostigmine had no affect on her disturbed behavior, so she was given midazolam 5 mg, went to sleep and recovered consciousness six hours later. No blood gases were taken from her. Her baby was also in a satisfactory condition.
On Monday 23rd July, a senior anaesthetist removed all drugs from " operating room, and carried out a mechanical check of the anaesthesia machine, and on Tuesday 24th, a routine service of the machine was performed under the Hospital's maintenance contract. Neither of these checks included gas analysis.
Incident Again Points to Gas
Case 3: On Wednesday 25th July, during an identical general anaesthesia for Caesarean section, the patient developed multiple ventricular premature beats within three minutes of induction. The blood pressure fluctuated between hypertension and hypotension as nitrous oxide was alternately discontinued and reintroduced. On reversal, this patient was unresponsive, although breathing adequately. She took three hours to recover consciousness.
A more detailed check of the anaesthetic machine was now done, using a Cardiocap apparatus, originally to determine whether the halothane vaporizer was faulty but no leaks were detected with the vaporizer in the off position.
Tainted Tank Targeted
However, when the nitrous oxide flow-meter was turned on, the C02 reading rapidly went "off-scale:' Reduction of the How of "nitrous oxide" and increase in flow of oxygen suggested that the contents of the nitrous oxide cylinder were predominantly C02, and subsequent analysis proved it to be 95% C02, 5% air.
On inspection, although its valve was pin-indexed for nitrous oxide, most of the blue paint was missing from the cylinder, swept around the shoulder, and no label was present to indicate its contents.
In view of the fact that the same company had supplied this cylinder as had been involved in an earlier hypoxic death in Hong Kong when a liquid gas container (LGC) had been mistitled with nitrogen instead of oxygen, there was considerable publicity and alarm generated by this case.
The company's response has been to undertake a radical upgrading of its quality control measures, including the adoption of a new, tamper-proof seal complete with bar-code, and unless this seal is intact, hospitals have now been instructed not to accept delivery of cylinders. In the case of LGC'S, a certificate of purity which accompanies the vessel is valid for only 48 hours, and if expired, the LGC must be returned to the company for checking.
The most Rely explanation for the latest incident seems to be that an illicit gas-filling and merchandising business was being operated by a person or persons on the company staff, and one of the products of this black market found its way into the normal stockpile. Though an exhaustive inquiry into the previous bulk liquid oxygen accident failed to establish how the misfilling with nitrogen occurred, one plausible theory is that on that occasion the oxygen LGC was misfilled by an industrial user who had an urgent need for nitrogen, an empty oxygen LCG, and a friendly business associate who was prepared to decant some nitrogen into the LGC for him. Wry little of the contents were used before the 'oxygen' LGC was returned to the company in exchange for a new delivery. Back at the company yard, the "oxygen" LGC was noted to be nearly full (although mistakenly with nitrogen), and as was the practice at that time, was "topped up" and reissued, this time to a hospital.
It has since been pointed out by anaesthesiologists and others that medical and industrial gas supplies should be segregated, at least as far as gas containers, stockpiles, and distribution are concerned. A changeover of all medical compressed go containers (CGC's) to pin-indexing is now being undertaken in Hong Kong, which will effectively segregate medical and industrial CGC'S. Since LGC's cannot be effectively "sealed " their problem has been handled differently, with each container being tested prior to leaving the company premises, and accompanied by the above mentioned certificate.
The clinical features of these cases will be reported more fully in the appropriate literature, but it is interesting to note that only one patient (case 2) presented the unconventional picture of hypercarbia (tachycardia and hypertension), and no doubt the diverse abnormalities manifested by these patients delayed appreciation of the true cause of the problem.
The de-bate on monitoring was also reactivated by these events. A committee of anesthesiologists, convened to advise the government of Hong Kong, pointed out that although capnography would have enabled this problem to be diagnosed earlier, the function of monitoring is not to substitute for quality control on the part of the manufacturer. The medical and hospital community have a right to expect purity of medicaments, including medical gases, from their suppliers. Fortunately, as far as Hong Kong is concerned, the steps which have now been taken by the company are reassuringly strict, and the possibility that episode such as those of 1989 and 1990 will be repeated, appears negligible
Professor Ross Holland, at the time of this writing, was Professor and Head, Department of Anesthesiology, Queen Mary Hospital, University of Hong Kong.
Back to Table of Contents
Radio Distracts, Competes; Should he Banned From OR
To the Editor:
Doctor Evamarie Malsch is absolutely correct with her statement that a radio has no place in the operating room.
As a specialty, we promote patient safety during anesthesia by advancing various monitoring standards. Yet, we allow auditory alarm signals to compete with the radio for our attention and subsequently our interaction. This extraneous sound can interfere with the ability to focus complete attention on our patients during critical points in their care.
This distraction extends to the surgical care team, as time is spent discussing channel changes, recording artists, etc. I feel this is a very real problem which needs to be addressed by the medical community before it is addressed by our insurance carriers and the legal profession.
James M. Quinn, M.D. The Cambridge Hospital Cambridge, MA
Music Appreciated; Not Threat
To the Editor:
I was moist surprised by the tone of the letter of Dr. Evamarie Malsch that appeared in the APSF Newsletter for Fall 1990 on the use of the radio in the operating room.
Many of my patients have appreciated back ground music during procedures that require regional and/or intravenous sedation. Most of our surgeons and operating room staff have also appreciated the appropriate musical setting for their endeavors. These things do improve patient care.
Music in the operating rooms at our institution is always under the control of the anesthesiologist and this is totally dependent upon the patient's condition and situations encountered.
I believe that when handled correctly, music may be used in the operating room without any decrease in vigilance. It all depends on the judicious use of the on/off and volume switch.
Marc B. Ehrenpreis, M.D.
Booth Memorial Medical Center, flushing, New York
Data Lack Causes Opposition
To the Editor:
In response to Dr. Malsch's letter "O.R. Radio Seen as Threat" (APSF Newsletter 5(3):2 7, Fall 1990), I would like to emphasize and amplify her concerns. I have never tolerated a radio or other source of music in an operating room for precisely the reasons that she so clearly defines. I have supported my colleagues and residents to be equally demanding in having these devices excluded from their place of work. To my surprise there is little support for this obvious safety precaution. Many of my colleagues claim that they like soft background music and believe it assists in maintaining an appropriate atmosphere in the operating room.
Research has been done on the beneficial effects of different types of music in various types of working environment. To my knowledge, however, none has been performed in the operating room I would like to inquire as to whether there is such information available
In the absence of appropriate information I will continue to exclude this source of irritation while others appear to welcome it!
Alan W Grogono, M.D. Chairman and Professor of Anesthesiology Tulane Medical Center, New Orleans
Capnography Seen Advantage to Awake Patients
To the Editor:
The Summer 1990 article "APSF-Sponsored Research Reveals that Capnograph Supplements Oximeter" was of particular interest to us. That study involved pediatric patients undergoing general anesthesia and suggested that capnography "appears to make significant contribution toward the care of pediatric patients by detecting problems related to ventilation that do not necessarily lead to hypoxemia, such as hypercarbia and hypocarbia."
The merits of capnography during intubation and general anesthesia have been universally accepted, specifically its ability to detect esophageal tube placement, disconnection, obstruction, mechanical failure, and air embolism. Problems haw been encountered, however, when used with pediatric patients or in situations where intubation was not required.
Our own research interests involve the use of capnography to follow respiratory status during regional and monitored anesthesia care (MAC) in the operating room. Additionally, me am examining the use of capnography for ventilatory monitoring during post anesthesia cam Being in a Veterans Administration hospital, our patient population is very different from that of the pediatric study. However, with the extremes of age, there are some pulmonary and cardiac similarities between the two patient groups, specifically with regards to limited reserves. The majority of our patients are chronic smokers with both cardiovascular and pulmonary disease which complicate their management compared to nonsmokers. We are interested in the possible alterations in ventilatory response in these patients with COPD in the presence of sedation, anesthetic agents, and supplemental oxygen use during MAC and post anesthesia care.
Until the advent of end-tidal C02 (ETC02) and/or mass spectroscopy, pulse oximetry, and ventilatory rate have been the only convenient means to follow ventilation in non-intubated, spontaneously breathing patients. An arterial line is invasive and provides only intermittent data. Recently methods have been developed for use with nasal prongs to follow ETC02. (1,2,3) They provide a somewhat accurate and reproducible means to follow trends in ventilation. Transcutaneous C02 electrodes have also been developed and correlated with arterial C02 but they require a long equilibration time and can produce cutaneous bums. (4)
Our preliminary data for patients in the operating room and the post anesthesia room suggests that there is a small but significant percentage of these patients who experience episodes of hypoventilation (hypercarbia) which are not detected by respiratory rate and pulse oximetry since rate and oxygen saturation can remain satisfactory. The majority of these episodes were transient. However, occasionally the trend continued or progressed. They occurred predominantly in the post anesthesia room where numerous etiological factors could play a role.
Although the final analysis of our data is pending and will be reported in dew, we presently believe that the statement quoted in the first paragraph above may also be applicable to our patient population and possibly to surgical patients in general.
Dean L. Melnyk, M.D., Ph.D. Shep Cohen, M.D. St. Paul, MN
1. Bowe EA, Boyen PG, Broome JA, and Klein EF. Accurate determination of end-tidal carbon dioxide during administration of oxygen by nasal cannulae. J. Clin. Monitoring 1989;5:105-15.
2. Desniarattes R, Kennedy R, Davis DR. Inexpensive capnography during monitored anesthesia care. Anesth Analg 1990;71:100-6.
3. Ibarra E. Len DE. Mass spectrometer monitoring of patients with regional anesthesia (letter). Anesthesiology 1985;63:572-3.
4. Shapiro BA and Cane RD. Blood gas monitoring: Yesterday, today and tomorrow, Crit. Care Mod. 1989; 17:573-8 1.
Letters to the Editor: On Neuro CVP Placement
To the Editor:
Dr. Lee A. Balaklaw raised a valid concern about positioning a catheter in the right atrium for the purposes of air aspiration since & September 1989 guidelines (APSF Newsletter 4:28, 1989) on central venous catheter safety noted that the catheter tip should not be placed in the heart.
Bunegin, et. al., found that maximal air aspiration from a single orificed catheter occurred when the tip was located in the superior vena cava (SVC) about 1.0 cm outside to the border of the right atrium (RA). On the other hand, they found that the optimal aspiration of air from a multiorificed catheter occurred when the tip was 0.5 cm into the RA. (1) Colley and Artru compared efficacy of air aspiration between the Cook mulfiorificed CVP catheter, the American Edwards 7F Swan-Ganz catheter (RA part) and the single orifice Sorenson CVP kit catheter. (2) They found the Cook multiorificed catheter to be superior in air aspiration characteristics than the other two catheters. Topographically, the proximal orifice of this multiorificed catheter was in the SVC (0.5-1.5 cm above the SVC-RA junction) and the distal part in the mid RA. From this data it appeared that we should not be constrained by the recommendations of the "Central Venous Catheter Safety Guidelines Task Force" when it comes to the question of using a central fine whose main purpose is for air aspiration.
Venous air embolism (VAE) can be a hazardous sequelae during neurosurgical procedures in the sitting position, or in any other surgical procedure where the heart is dependent to the surgical area and air can be entrained. A properly placed central venous fine is the hallmark for both the verification and treatment of VAE. (3)
We are conscious of the problems involved with catheter placement in the heart chambers and are in the process of testing a silicone rubber version of the Cook multiorificed air aspiration catheter. We believe that the lack of rigidity of silicone rubber would minimize the penetration of the heart chambers seen with the stiff plastic material used in the catheter manufacturing process.
Maurice S. Albin, M.D., M.Sc. (Anes.) Leonid Bunegin, B.S. Rosemary Hickey, M.D. Tod Sloan, M.D., Ph.D.
The Neuroanesthesia Service, Department of Anesthesiology, University of Texas Health Science Center, San Antonio, TX.
1. Bunegin L, Albin NE, Helsel PE, Hoffman A, Hung TK: Positioning the right atrial catheter: a model for appraisal, Anesthesiology 55:343-358, 198 1.
2. Colley PS, Artru AA: Bunegin-Albin catheter improves air retrieval and resuscitation from lethal venous air embolism in dogs. Anesth Analg 66:991-994, 1987.
3. Albin MS, Carroll RG, Maroon JC: Clinical considerations concerning detection of venous air embolism. Neurosurgery 3:3W384,1978.
Position Varies; Gown Needed
To the Editor:
The commentary of Dr. Bakalaw in the Summer 1990 issue of the Anesthesia Patient Safety Foundation Newsletter related to the "Central Venous Safety Guidelines" issued by the Food and Drug Administration Central Venous Catheter Marketing Group raises interesting issues. As the ASA representative to the group, I feel strongly that if a clinician thinks it is in the best interest of & patient to place a catheter tip in the right atrium, then he should do so. There is no consensus about the best position of the catheter tip for aspirations of air; some advocate placing the tip above the right atrium.
Since infections are common, wearing a gown seems to be a reasonable precaution. While it surely won't prevent infection by itself, it helps to reduce sites from contamination and to raise awarenss that placing a central venous or pulmonary artery catheter is as invasive as many a surgical procedure. A general approach to providing care that abides by the highest practical level of sterility, I think, is what drove the group to suggest gowns.
The working group has worked to promote safety on other fronts. At present, we are producing a video tape on avoiding complications with central venous catheters.
David A. Paulus, M.D. Associate Professor of Anesthesiology and Mechanical Engineering, University of Florida, Gainesville
To the Editor:
In the Summer 1990 issue, Dr. Lee Balaklaw raises the question of the optimal positioning of a central venous catheter for the aspiration of air embolism during neurosurgery in the sitting position. In 1981, Bunegin et. al. (1,2) following experiments with a silastic rubber atrium model, suggested that the best recovery of air was obtained with the catheter tip in the vena cava, not the heart. They recommended the use of a multiple-orifice catheter with the tip located 2 cm below the junction of the superior vena cava and the atrial cavity. If a single (terminal) orifice catheter was used, the best position of the tip was 3 cm above the junction. In either case the catheter did not enter the atrium.
As far as I know, this work has not been confirmed in human subject, nor has it been refuted. It is our practice to insert the catheter via the antecubital vein under fluoroscopic control. A method has also been described of using the saline-filled catheter as one lead of an ECG and observing a bipolarity followed by inversion of the P wave as the catheter is advanced 3, but this method could involve significant micro-shock hazards.
Peter H. Byles, M.D. SUNY Health Science Center
Syracuse, New York
1. Bunegin L, Albin MS, Helsel PE, Hoffman A and Hung TK: Positioning the right atrial catheter: A model for reappraisal. Anesthesiology 1981; 55:343-348.
2. Mitchenfelder JD: Central venous catheter in the management of air embolism: whether as well as where (Editorial). Anesthesiology 1981; 55:339-341.
3. Shapiro H, in: Monitoring in Anesthesia, Saidman LJ and Smith NT (Eds), Chapter 8. Boston: Butterworth, 1984.
Uncovered PACU Appears Acceptable Standard
To the Editor:
Dr. Balaklaw wonders (APSF Newsletter, Summer 1990) whether his mode of practice (not routinely have a "free" anesthesiologist available to deal with problems in the PACU) meets my standards. While I was not aware that anyone had appointed me an authority on the standard of care for medical coverage of a PACU (1), I would make the following comments:
According to his letter, Dr. Balaklaw works in a hospital setting, where there is a cardiac arrest team immediately available on call to handle cardiorespiratory emergencies. He notes that this team includes a number of individuals who are skilled in airway management techniques. His situation is, therefore very different from that of Dr. Figueroa, whose letter prompted my earlier comments (APSF Newsletter, September 1989). The latter physician worked in a free-standing Suigicenter, where no other comparably trained personnel were available. In my previous letter, I opined that: "An anesthesiologist who commences the "solo" administration of anesthesia to a patient for an elective case, leaving other patients for whom he has accepted responsibility in the recovery room without the immediate availability of another appropriately skilled and qualified individual to render needed emergency care [new emphasis] is, to my mind, already guilty of abandoning those patients." Although I would regard the circumstances of Dr. Balaklaw's practice as less than ideal, and would personally be very uncomfortable with not having an anesthesiologist available to deal with potential problem in the PACU, I am inclined to agree with him that his practice mode meets a reasonable standard of cam
Peter R. Fletcher, M.A., B.M., B.Ch. Delaware County Memorial Hospital, Drexel Hill, PA
Back to Table of Contents
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.
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
Back to Table of Contents