Leadership and Quality Care in
From the Literature
ECRI Identifies Anesthesia Equipment Hazards
Current Questions in Patient Safety
By James E. Eckenhoff, M.D.
A contemplation of the problems of quality control in anesthetic practice suggests that one solution too often ignored is the identification and appointment of capable leaders who are given and will accept the authority to see that appropriate standards for education and patient care are set. If the chief of an anesthesia department is appointed on the basis of seniority alone, or a system is established where the members of a department serve as chief on a rotational basis, then I believe in most instances the department is doomed to mediocrity resulting in substandard medical care. This is not confined to anesthesia; it is true of any department. Leaders must be appointed by virtue of demonstrated qualifications:
1. Someone who understands the need for organization. A leader must be able to recognize and appoint capable lieutenants, delineate and delegate authority, define standards and goals, and expect in return appropriate performance.
2. A good business manager. It is difficult to believe that one can be a leader today in a health care area without understanding good business management. We have become cost conscious and realize that in the past we often were inefficient and wasteful. It is interesting to watch physicians set up their own for-profit organization or even a fee-for-service, not-for-profit department in an academic setting. When it is their money that is being spent or wasted, cost consciousness develops overnight. This, of course, is one basis for the recent development of chains of for-profit hospitals, which often stay away from tertiary care; it is too costly. Yet, in what they do, they attempt to provide equally good health care, and make a profit. A health care system without incentives is unlikely to compete effectively with systems that do have incentives.
3. One who can communicate effectively. Communication is the essence of leadership; without this ability, one cannot lead. In my experiences as dean of a medical school for 13 years, the chiefs who Sot into difficulties with their staff or the dean's office displayed an inability to communicate well, hence they were ineffective leaders, yet, of note in every instance, they were excellent clinicians or scientists.
The leader is also to some extent "his brother's keeper." One must become aware of personal problems of staff and associates that may affect maximal performance. Similarly, the leader must be sensitive to physical or personality changes in departmental members that may suggest disease.
4. One who can establish credibility. A leader must be fair, recognize that there are two sides to every argument, be reliable in carrying through on what has been agreed to, and not be subject to snap judgments that too often have to be reversed.
5. A long range planner and developer. Too often, the members of an anesthesia department get bogged down in doing nothing but providing daily service taking care of the operative schedules. Their entire focus is on what needs to be done today with no one planning for the future. A personal example of long range planning concerns an early experience with Bob Dripps, a legendary name in anesthesia. When I returned to Pennsylvania after World War II and requested pharmacology training before working in the clinical situation, I learned midway in the training that the clinical anesthesia coverage was inadequate. I offered to give up pharmacology and help in the operating room. Dripps' response was prompt and unforgettable because, as I now realize, it portrayed the great leader he was, "No, Jim, stay where you are. Two years from now you will be invaluable to anesthesia for your pharmacology training. Two years from now, no one will remember the day-to-day frustrations that we are now experiencing."
Included in long-range planning is the development of one or more top associates who, if the leader becomes ill, would be qualified to take his/her place immediately. I would suggest that leaders should look within their departments and see if they have such backup, and if they don't, why not? It is interesting how often chairmen, deans, and college or hospital presidents do not have strong number two persons. Sometimes developing number two hasn't been thought of or wasn't a top priority. More often the reason is the leader's lack of security and the fear that if number two becomes too strong, he/she might be asked to take over number one's job. Also strong number twos will be recognized by others and may be recruited away, but true quality programs are those that supply leaders to other institutions.
6. The leader of a clinical discipline must recognize that the discipline cannot function in a vacuum. There must be interdisciplinary teaching as well as a joint collaboration in patient care. Departmental chairmen and chiefs of service should meet with CEO's regularly to discuss common problems, solutions to clinical concerns, standards of care, the impact of impending changes in health care delivery, budgets, and staffing complements. For this sort of interdisciplinary discussion to be successful, all chairmen must be of equal status.
Speaking specifically of anesthesiologists, I find it discouraging that some consider themselves of inferior status compared to surgeons, internists, or obstetricians. I certainly have never felt that way but I recognize there have been times I had to prove my knowledge compared to others. An anesthesiologist certainly does not establish status by taking refuse behind an ether screen or confining his activities to operating rooms. Also, causes of anesthetic complications must be discussed with all disciplines concerned. I don't consider mortality and morbidity studies as self flagellation. Serving as a base for thoughtful discussion and carefully filed away, such studies can become important in the future. I can think of three syndromes resulting in death that were not understood in our initial reviews but are now fully explained: the absorption of distilled water during transurethral prostatic resection resulting in hemolysis, hypertension, muscle rigidity, and kidney failure; the malignant hyperthermia syndrome; and cardiac arrest that may follow the intravenous injection of succinylcholine in the paraplegic patient. I'm sure that there are additional examples.
7. A leader must recognize the importance of intellectual curiosity and research in maintaining and upgrading the standards of both medical cam and of teaching. Clinical programs that are bereft of libraries, seminars, case discussion meetings, and continuing education programs are likely to be below average. The absence of consultants, attendings, or faculty who will challenge the intellect of medical students and house staff can only lead to generations of doctors who will practice with unacceptable standards. Worse, in my personal estimation, would be the absence of medical students and house officers to challenge and question the faculty, attendings, or consulting doctors.
8. A final point in my litany of the attributes of a good leader. A leader must become divorced from personal gratification in the leadership role and substitute the pride of accomplishment of a department (or school or hospital) as it deals with the present and plans for the future I am dismissed with the number of faculty and chairman who conceive it to be their right to travel a major proportion of their time I know no leader who absents herself a majority of the time, year after year, who runs a good department or has a high caliber teaching program.
Physicians have traditionally preferred an independent and some an entrepreneurial approach to health care delivery. They do not like regimentation, direction, rules for practice, or anyone looking over their shoulders. But the practice of medicine has changed and is no longer a matter solely between a physician and a patient. Hospitals and physicians must respond to the recommendations of the Joint Commission on Accreditation of Hospitals as well as to professional, societal, and legal pressures of assuring quality control in the delivery of health care. Quality health care is a vast interest to the public. The public is the consumer, so we can expert that more and more will appear in our public press, leading to greater pressure on medicine. As much as we all abhor malpractice actions, we have to accept that there is some malpractice. We may be unsatisfied with the current climate, but let us not deny that we do have trouble that justifies some litigation.
In this country, clinical chairmen and service chiefs are being charged with annually approving the clinical privileges of those who work in their departments. In other words, the leaders must police the competence of their staffs. If the chairman cannot approve privileges due to compromised competence, then the physician should resign from the staff. In some examples of this, there were tortuous due-process procedures and, in several instances, charges that an institution should have known sooner the person was incompetent and thus didn't remove privileges fast enough. This system puts a lot of pressure on a chairman or a chief, a pressure that may be inevitable even though it is mandatory for patient safety.
In addition to physicians surveying the competence of physicians, more and more hospitals have a staff-administration-trustees' committee that regularly meets with a chairman or section chief to review the methods by which a department maintains quality control. In the event of malpractice action against a physician, the hospital is likely to be drawn into the suit to see if appropriate methods were in place to assure quality care and competence. One of the spin-off benefits of these so-called standards committees is that it forces administrators and board members to rub elbows with the physician and to discuss common problems.
Societal forces, governmental regulation, and legal pressures are causing us to change our ways of practice and effecting a very visible standard of care. Only with good leadership in the clinical arena can we adequately respond.
An abridged version of a lecture given before a seminar of the Royal Society of Medicine, London, and published in "Quality of Care and Anesthetic Practice" edited by J.N.Lunn, MacMillan Press, ltd, 1984.
Dr. Eckenhoff is Dean and Professor Emeritus, Northwestern University Medical School, and VA Distinguished Physician.
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Editor's note: In each APSF Newsletter, a pertinent Publication from the anesthesia patient safety literature will be summarized. Suggestions for future issues are welcome.
ECRI Technology Assessment. Deaths during general anesthesia. 1. Health Care Tech. 1: 155 175, 1985.
"Deaths During General Anesthesia" is must reading for every anesthesiologist if only because it will be read by hospital administrators who control capital budgets. The article appears to be the collective product of the staff of the ECRI.
The article starts out with a very good description of the extent of preventable anesthetic mortality and a review of the underlying factors. Cooper's study of anesthetic incidents is summarized and the experience of several insurance companies reviewed. The potential costs of insurance losses alone are remarkable. If one only counts the estimated 1000 preventable deaths, and multiplies that by the reported average of $100,000 loss per case of all types (excluding minor costs attributed to damage to teeth), the yearly loss is one-tenth of a billion dollars. One can reasonably assume that this estimate is very conservative of total potential cost.
The article's analysis of what can be done to prevent unnecessary morbidity and mortality is not as strong as the description of the problem. For reasons not clear to this reviewer, the authors appear to accept the premise that it would be too costly to institute procedures (including use of modem equipment) to really address the problem; this despite the high cost of preventable losses. They state that since "few hospitals can afford to replace all their obsolete equipment . . . anesthetists must tolerate ... deficiencies such as dangerously arranged controls and gauges." Such complacent thinking in 1986 defies logic and makes one pause before criticizing the plaintiffs bar. Indeed, the courts are setting standards by case law while the profession debates their necessity.
The authors content themselves with suggesting the universal adoption of "two relatively inexpensive technologies:" circuit oxygen analyzers and circuit low pressure alarms. They, however, state that capnography "comes closest to being a fail-safe monitor for most problems that can cause anoxia and death" and that pulse oximetry "provides a more clinically useful measure than any anesthesia safety device now in common use" while failing to advocate their general use
The article is marred by errors which may be due to the authors not being aware of the most recent technology They correctly point out that battery exhaustion is a problem with circuit oxygen analyzers while failing to acknowledge the existence of line-operated devices. They are concerned that oxygen analyzers may not be turned on, while not reporting that with many modem anesthesia machined, the analyzer is automatically on when the machine is on. They warn against the confusion of multiple alarms, while not noting that integrated system with alarm priorities are becoming available
Finally, they consistently refer to circuit low pressure alarms as "disconnect alarm," although this unfortunate misnomer may be the reason that far more reliable methods of detecting catastrophic disconnection such as capnography are not yet universally used.
Despite deficiencies, this is a valuable contribution because of the way it organizes a great deal of information and presents critical issues. It could well serve as a starting point for discussions within an anesthesia department concerning preventable deaths.
Abstracted by Ralph A. Epstein, M.D., Professor and Chairman, Dept. of Anesthesiology, University of Connecticut
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By Ronni P. Solomon
ECRI SCIENTIST Guy Knickerbocker, Ph.D and Robert Spooner, Ph.D. examine and test an anesthesia machine as
part of the on-going study of potential anesthesia equipment hazards
Despite the efforts of many groups, serious anesthesia equipment-related mishaps continue to occur. Anesthesia scavenging systems, vaporizers, breathing circuits, and ventilators have been implicated in patient deaths and injuries and occasional injuries to operating room personnel. When it comes to analyzing the cause of an accident or failure, many questions arise: Was there a device design defect? A random component failure? A manufacturing defect? Faulty maintenance or pre-use inspection? Operator error? Sabotage? Or was injury or death the result of an abnormal or idiosyncratic physiologic response to otherwise normal conditions of use and performance for that device?
ECRI has been answering these questions for nearly two decades. FICRI is a non-profit, tax-exempt research institute located in suburban Philadelphia. To maintain maximum objectivity, neither ECRI nor its staff has a direct or indirect financial interest in the sale of medical devices, and no royalties, gifts, or commissions are accepted from the medical device or hospital equipment industry.
ECRI investigates, analyzes, and helps to prevent anesthesia equipment-related incidents throughout the world. Anesthesia personnel may be familiar with Technology for Anesthesia, an ECRI news-letter that evaluates products, provides device operation recommendations, and reports equipment related hazards. The organization maintains the world's largest and most up-to-date computer database on medical device problems with more than 60,000 reports on file. Information is derived from a number of sources including medical, legal, engineering, and scientific literature; government reports (U.S. and international); and ECRI's own clinical and Laboratory research, reporting systems, and detailed forensic investigations.
ECRI's commitment to safe health care technology and, in particular, anesthesia safety, has contributed to a number of worldwide patient safety initiatives. For example in 1982, ECRI issued its anesthesia system pre-use check , which was extensively tested and reviewed prior to publication. The check list was distributed at the American Association of Nurse Anesthesists annual meeting in 1982, and was subsequently updated in 1984 to include a sample check of vaporizers to detect excessive output. ECRI has also published numerous policies and procedures for inspection, maintenance, and safe and effective use of anesthesia equipment, and has long advocated use of oxygen analyzers. ECRI has conducted many detailed evaluations of equipment used in the anesthesia department, such as EKG monitors, ventilators, capnographs, patient monitoring equipment, and peep valves, the results of which have been published in its journal Health Devices. Standards-issuing organizations, such as the ASTM, have called on ECRI staff for assistance in anesthesia equipment standards development, and medical device manufacturers have modified equipment on the basis of ECRI's published evaluations, hazard reports, and engineering safety recommendations.
ECRI maintains a vital, ongoing hazard communications link with over 3,000 hospitals through its Health Devices Alerts program, a weekly service that provides abstracts of medical device problems accompanied by action recommendations, procedures, and forms, where appropriate. This program includes not only manufacturer- initiated or FDA reports, but also hazards that are reported by hospitals worldwide, directly to ECRI. All of these reports are verified by ECRI. Through this hazard reporting and communication system, anesthesia personnel remain alert to such problems, and take steps that will eliminate or reduce the risks to patients.
In addition to its Health Devices System, ECRI offers several technology and risk management information services to the health care, legal, and insurance communities. Through ECRI's Select (TM) program, equipment analysis are also available. They include a detailed examination of the state of the art, reported and potential risks, technical and clinical comparisons, life cycle cost analyses, and recommendations for specific brand name equipment and models.
Ms. Solomon is Program Director, Hospital Ri5k Control, ECM, 5200 Butler Pike; Plymouth Meeting, PA 19462.
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Current Questions in Patient Safety
Question How does one best verify that the endotracheal tube is in correct position after intubation?
Answer: Over the years, many techniques have been used to verify proper placement of the endotrachal tube. In the past, verification relied on visual confirmation of bilateral movement of the chest during positive pressure ventilation, on auscultation of the chest with a stethoscope, and on the appearance of vapor in the endotracheal tube on exhalation. Some have been known to press on the chest and listen for expulsion of air; others have actually attached whistles to the endotracheal tube.
Of these techniques, the most reliable is bilateral auscultation of the chest. However, one can be misled, particularly with a small child, in whom sounds are readily transmitted, or with an extremely obese person, in whom breath sounds may be very difficult to hear adequately. For reliable auscultation, I recommend that the chest be auscultated in at least two places bilaterally, one of which should be the midaxillary line. Also, one should listen over the epigastrium.
Newly introduced equipment that gives breath-by-breath analysis of carbon dioxide tension gives certainty that the endotracheal tube is in the trachea, as opposed to the esophagus, by detecting an appropriate level of end-tidal carbon dioxide with each breath. This can be done with a dedicated carbon dioxide analyzer or with a mass spectrometer. If carbon dioxide is not detected on exhalation and the equipment is working properly, the endotracheal tube is certainly misplaced or totally obstructed.
End-tidal carbon dioxide monitoring does not readily detect endobronchial intubation. An endobronchial intubation frequently can be detected by recognizing a difference in the breath sounds transmitted from the two sides of the chest by auscultation or, more accurately, by roentgenogram. Unfortunately, the latter is not readily available for routine use during anesthesia.
Monitoring the patient's oxygenation with an oximeter can detect when the endotracheal tube is not in the trachea and may suggest when a tube is placed in one or the other main stem bronchi. However, particularly after the patient has been preoxygenated, oximetry may delay the detection of a faulty intubation because oxygen desaturation does not occur instantly.
My recommendation is that, after endotracheal intubation, bilateral auscultation of the chest in at least two places and auscultation over the epigastrium be done routinely. If the capability exists to measure end-tidal carbon dioxide tension, then this should be done on a routine basis. Further, patients in whom endotracheal tubes are placed for long-term ventilation, such as those in the intensive care unit, should have a follow-up chest roentgenogram.
Response by: Jerome H. Modell, M.D., Professor and Chairman, Dept. of Anesthesiology, University of Florida.