See the original article online at: https://www.apsf.org/article/asa-adopts-basic-monitoring-standards/
Anesthesia professionals who trained after the late 1980s have never known a time without “routine ASA monitors,” often represented on the anesthesia record by a check box indicating compliance with the American Society of Anesthesiologists Standards for Basic Anesthetic Monitoring, meaning the application and correct use of routine essential monitoring.
How those precedent-setting standards—the first ever detailed, explicit, minute-to-minute requirements for daily procedural practice in modern health care—came to be, and their implications for improved safety of all anesthetized patients, is a story that debuted in one of the very early issues of the APSF Newsletter.1
The ASA House of Delegates adopted the monitoring standards as official policy at the October, 1986 Annual Meeting. In spite of advance notice, discussion, and advocacy “politicking,” there was initially some concern by the organizers and sponsors of the resolution that there could be opposition to the proposed standards simply because people (and likely physicians in particular) often do not like being told what they must do. However, the proposed elements of conduct during all anesthetics for surgery (labor epidurals were excluded) were so logical as to be essentially obvious and were already being practiced in their own way by a majority of American anesthesia professionals. The resolution passed easily.
The Original Standards
Formulated and offered to the ASA membership by the brand-new Committee on Standards of Care, the original ASA monitoring standards were simple and straightforward. They opened with some caveats recognizing that there might be circumstances in which the standards could not be followed. There were even explicit definitions of the words “continuous” and “continual” in order to provide perfectly clear understanding of the requirements. The first standard mandated that qualified anesthesia personnel be present in the room throughout the conduct of all anesthetics. However obvious this may be to anesthesia professionals in 2020, the fact is that even into the 1980s, it was not unheard of for anesthesia practitioners to leave a patient on a ventilator in an OR in order to take a break or secure medication/equipment. Well-publicized sad (and expensive) patient-injury accidents resulting from that old habit motivated the ASA standards committee to make it explicitly clear that this practice would be absolutely forbidden.
A critical point that possibly was not emphasized enough to the broad anesthesia community at the time was the very important distinction between behavior and technology. The goal of the behavior that would come to be known as “safety monitoring” for the anesthetized patient was to provide the earliest possible warning of untoward dangerous developments during anesthesia that, unrecognized or left unattended, would injure the patient (the definition of a “critical incident”), providing time for diagnosis and treatment before injury could occur. While technologic devices were prescribed or encouraged as methods to affect the behaviors and, understandably, later became the focus of the implementation of the standards, the real underlying objective was to create a required environment of continuous, every-moment attention to the key monitoring elements. Accordingly, with the monitoring standards, forever abandoned and laid to rest then was the stereotyped “old way” of about every five minutes scanning around the anesthetizing location to see if things looked okay, recording vital signs on the handwritten anesthesia record, and then, for some practitioners, returning attention to the crossword puzzle, stock market pages, or whatever (as sometimes satirized in cartoons or by surgeons).
The second of the two standards consisted of a section for each of the four elements of classic monitoring: oxygenation, ventilation, circulation, and temperature. For clarity, each section first stated the objective for the monitoring and then the methods specified to meet that objective.
Oxygenation monitoring first required an inspired gas oxygen analyzer. Tragic accidents had occurred from accidental discontinuation of O2 flow, either from user error or supply failure. Then, blood oxygenation was the main focus of the desire for the earliest possible warning of developing hypoxemia. “Qualitative signs” (patient color) were mentioned, and pulse oximetry was only “encouraged” in the original 1986 version. This was somewhat controversial because some anesthesia professionals already recognized the unique value of pulse oximetry and thought it should be mandatory. The instruments were just coming into wider use in early 1986. Wanting to avoid mandating a technology not yet universally available and knowing it would soon become a required standard, the committee elected to wait for the inevitable first revision of the standards, which came in 1989, when continuous pulse oximetry during anesthesia care became the official standard of care across the profession.
Monitoring ventilation, the heart of anesthesia care, received the most attention in the original standards, which called for the continual qualitative evaluation of ventilation. Again, the technology of capnography was just becoming more widely available and its use for both verification of correct endotracheal tube placement and continuous ventilation monitoring was “encouraged,” but not yet officially mandated (which was done in subsequent years). Also, based on a significant number of anesthesia injury accident reports, use of a ventilator disconnect monitor with an audible alarm was mandated as the standard of care during mechanical ventilation. Finally, as a harbinger of things to come in later years, “the adequacy of ventilation shall be evaluated, at least, by continual observation of qualitative clinical signs” during regional anesthesia and monitored anesthesia care.
Monitoring of circulation included mandatory continuous ECG tracing display, measurement of blood pressure and heart rate at least every 5 minutes, and continual evaluation of circulatory function in any of various ways, but particularly including mention of the plethysmograph of a pulse oximeter tracing.
Temperature monitoring, initially and then for many years, was the “fuzziest” of the standards. An immediately available means of temperature monitoring was required along with the well-known mandate: “When changes in body temperature are intended, anticipated or suspected, the temperature shall be measured.”
Genesis of the Standards
Starting in the mid 1970s, there was a critical explosion of medical malpractice lawsuits in the U.S. (the “malpractice crisis”) resulting in extremely expensive and dramatic settlements and jury awards from anesthesia accidents, all of which received widespread publicity, particularly from a 1982 ABC Television special about anesthesia catastrophes: “The Deep Sleep: 6000 Will Die or Suffer Brain Damage.” 1984 ASA President, the late Ellison C. (“Jeep”) Pierce, Jr., MD, of Harvard (and later the inaugural President of the APSF) was profoundly concerned about this problem, particularly anesthesia fatalities caused by very late recognition of accidental incorrect placement of endotracheal tubes into the esophagus. He proposed and initiated the creation of the ASA standards committee, urging it to address these issues. Burton S. Epstein, MD, from George Washington, was chairman, and John H. Eichhorn, MD, of Harvard was the secretary, who brought the not-yet-published “Harvard monitoring standards”2 to the committee as an example of an approach taken in an attempt to reduce preventable severe anesthesia accidents. In the early 1980s at Harvard’s 9 teaching hospitals, anesthesiologists constituted 3% of the faculty (common at the time), but accounted for over 12% of the malpractice insurance pay-outs, which approximated the national statistics.3 This perceived excessive danger led a “Harvard risk management committee” chaired by John Eichhorn to create a 1985 set of anesthesia standards as a response, and these Harvard standards became a template for the ASA subsequent efforts, as comparing the two makes apparent. Both committees understood that it was critical to impress upon anesthesia professionals the necessity of changing behavior in order to help prevent injury accidents. Accordingly, first at Harvard, and then by the ASA, the proposed intra-operative monitoring efforts were not labelled “recommendations” or “guidelines,” but, rather, specifically “standards of care.” This fact had enormous medical-legal implications and was unprecedented in American health care. When the ASA published detailed, required “standards” for practice, any accident causing patient injury during willful deviation from these standards would be a guaranteed automatic loser in a malpractice lawsuit—an obvious incentive for all practitioners to implement the monitoring prescribed by the standards.
As noted, many, if not most, anesthesia professionals had already adopted their own personal versions of several of the ideas. The published standards codified and clarified the required behaviors, prodded reluctant/resistant practitioners into compliance, and, importantly, introduced the concept of significantly enhancing the sensitivity and specificity of the human senses through application of the then-brand-new and genuinely innovative electronic monitoring technologies of pulse oximetry and capnography. The goal of this organized approach was to provide the earliest possible warning of any dangerous clinical developments, thus providing ample time for diagnosis and remedy before patient injury could occur. The fundamental idea of these standards constituted a “game-changer” for the anesthesia profession, as the late Paul G. Barash of Yale declared in 2015.4
In the late 1980s, it was quickly recognized that there would never be a prospective, controlled, randomized, “p<0.05” clinical trial to test the efficacy of “safety monitoring” as embodied in the monitoring standards. The cohorts would require truly massive numbers to hope for meaningful statistics regarding very low-frequency events, but, more importantly, the “no monitoring” control group would be both unethical and impossible to have patient-informed consent. However, a 1989 detailed retrospective analysis5 of the catastrophic anesthesia accidents among 1,001,000 ASA Class I and II patients at the Harvard hospitals that prompted the original concerns there suggested that the large majority of the injury accidents (representing 88% of the malpractice insurance pay-out) prior to the implementation of the “safety monitoring” specified in the standards would have been prevented by those strategies. A subsequent review6 covered additional patients and showed a more than fivefold reduction (to essentially zero) in catastrophic accidents after adoption/implementation of the standards. Probably the most significant validation of the concepts of safety monitoring in the monitoring standards, however, was the dramatic reduction in malpractice insurance costs to anesthesiologists. This trend was seen throughout the country,7 and, in 1990, the ASA leadership suggested: “Abiding by the ASA Standards for Basic Intra-Operative Monitoring and using pulse oximetry and capnography may result in significant savings for anesthesiologists now negotiating new policies.”7 The impact was particularly noted at Harvard, where, in 1989, malpractice insurance cost was cut 33% in one year.3,8 Overall, between 1986 and 1991, as personally experienced by this author, there was a 66% reduction in insurance premiums paid by anesthesia faculty. Because insurance company actuaries are inherently not charitable, this dramatic decrease resulted from the simple fact that there were far, far fewer and less severe anesthesia accidents, providing a form of “proof” (other than p<.05) that the monitoring concepts in the standards improved anesthesia patient safety.
The ASA Standards for Basic Intra-Operative Monitoring have been expanded slightly and tweaked several times in the more than 30 years since their adoption, including a name change to “anesthetic” monitoring9 to reflect their expanded scope, particularly the requirement for continuous capnography during all moderate or deep sedation (again reflecting the preeminence of ventilation in anesthesia care). However, all the original core elements, and their impact, persist. In part because of the enormity of the medical-legal implications, it is highly unlikely that the ASA will create any new detailed “standards of care” in the future. Furthermore, the ASA standards committee is now the “Committee on Standards and Practice Parameters.” The current approach to developing and implementing practice parameters (which, some can and do argue, are treated by plaintiffs’ malpractice attorneys as effectively standards of care) is staunchly evidence-based, involving exhaustive literature searching by cybrarians, intense professional statistical review and meta-analysis, and painstaking review and debate by subcommittees and the Committee on Standards and Practice Parameters, and the ASA House of Delegates. It could be imagined that a future generation of brain/CNS monitoring technology would claim to promote smoother general anesthesia using less anesthetic medication and faster recovery with lower incidence of cognitive disruption. It might then evolve to a status of performance and confidence that would meet the rigorous criteria for endorsement in an ASA practice parameter (even possibly establishing a new de facto standard of care). If so, this definitely would be announced on the front page of the APSF Newsletter, just as were the original monitoring standards in 1987. Times have evolved, however, and there is no real parallel with the ad hoc process of the 1980s generated by the acute need to address a perceived crisis. That process worked well at that time. The ultimate results, still immediately relevant today, changed fundamental anesthesia practice forever and, consequently, improved patient safety.
John Eichhorn, MD was the founding editor and publisher of the APSF Newsletter. He lives in San Jose, CA, as a retired professor of Anesthesiology, and continues to serve on the APSF Editorial Board.
The author has no conflicts of interest.
- Eichhorn JH. ASA adopts basic monitoring standards. APSF Newsletter. 1987;2:1. https://www.apsf.org/article/asa-adopts-basic-monitoring-standards/ Accessed August 12, 2020.
- Eichhorn JH, Cooper JB, Cullen DJ, et al. Standards for patient monitoring during anesthesia at Harvard Medical School. JAMA. 1986;256:1017–1020.
- Pierce EC. Anesthesiologists’ malpractice premiums declining. APSF Newsletter. 1989;4:1. https://www.apsf.org/article/anesthesiologists-malpractice-premiums-declining/ Accessed August 12, 2020.
- Barash P, Bieterman K, Hershey D. Game changers: The 20 most important anesthesia articles ever published. Anesth Analg. 2015;120:663–670.
- Eichhorn JH. Prevention of intraoperative anesthesia accidents and related severe injury through safety monitoring. Anesthesiology. 1989;70:572–577.
- Eichhorn JH. Monitoring standards: role of monitoring in reducing risk of anesthesia. Problems in Anesthesia. 2001; 13:430–443.
- Turpin SD. Anesthesiologists’ claims, insurance premiums reduced: improved safety cited. APSF Newsletter. 1990;5:1. https://www.apsf.org/article/anesthesiologists-claims-insurance-premiums-reduced-improved-safety-cited/ Accessed August 12, 2020.
- Holzer JE. Risk manager notes improvement in anesthesia losses. APSF Newsletter. 1989;4:3. https://www.apsf.org/article/risk-manager-notes-improvement-in-anesthesia-losses/ Accessed August 12, 2020.
- American Society of Anesthesiologists. Standards for Basic Anesthetic Monitoring, Last Amended: October 28, 2015. https://www.asahq.org/standards-and-guidelines/standards-for-basic-anesthetic-monitoring. Accessed June 29, 2020.