From the Literature: Standards of Care and Capnography

William Cass

Failure to Provide Capnograph. “Anesthesiology Malpractice Reporter”, Vol. 10, No. 2, March/April 1991, 1-2, 12.

Described in this monograph is a malpractice case in which a jury verdict was recently affirmed by the District of Columbia Court of Appeals. The issue was whether a reasonably prudent tertiary care hospital, at the time of the injury (November, 1987) and based on national standards, should have supplied an end-tidal carbon dioxide monitor (capnograph) for a patient undergoing general endotracheal anesthesia for elective surgery. The court held that the testimony of the medical expert and the chairman of the hospital’s department of anesthesiology as to the standard of care was sufficient to create an issue for a jury.

The case involved a nurse anesthetist supervised by an anesthesiologist who administered anesthesia to a previously healthy 36-year-old woman for an elective tubel ligation. She inserted an endotracheal tube and while she ventilated the patient, the anesthesiologist observed the rise and fag of the patient’s chest and listened for breath sounds on both sides Five minutes later, the surgeon notified the nurse anesthetist that the blood was dark. She checked and found the vital signs stable. Soon after, the patient suffered a cardiac arrest from which she was resuscitated. However, the patient remains disabled and completely unaware of her surroundings from hypoxic brain injury. The anesthesiologist and nurse anesthetist agreed to an out of court settlement with the plaintiff. The allegation that the hospital had a duty to provide a capnograph, on the unargued assumption that it would haw prevented the tragedy, was litigated. There was a jury award against the hospital. The hospital appealed, but without success.

Standards Questions

This case raises a number of questions:

1 . What is a standard of care?

2. Was there a standard of cam requiring the use of capnography in November, 1987?

3. If a standard of care is suggested or adopted by a professional organization, what are the members’ obligations?

4. If a standard of care involves the use of a specific piece of equipment which would normally be supplied by a hospital, what is the hospital’s responsibility and how soon must it buy the equipment?

5. Are hospitals held by the courts to similar standards of care as are physicians?

Eddy (1) states that to write a standard requiring “the use of an intervention, the main health and economic consequences must be known sufficiently well to permit decisions. There must be virtual unanimity among patients about the desirability of the outcome.” His definition of “virtual unanimity” of preferences is that at lease95 percent, perhaps even 99 percent (of patients) should agree on the desirability of the outcome. There is little doubt that all patients, on being informed that capnography is probably the most reliable method known to avoid esophageal intubation 2 would vote for such a standard. Eddy says that once adopted, a standard must be applied rigidly and must be followed in virtually all cases.

In trying to answer the question whether there was a standard requiring capnography in November, 1987, the following history must be considered. In August, 1986, Brimingham, Cheney, and Ward (2) published a review article on techniques to detect esophageal intubation. They discussed 16 commonly prescribed methods and found them all except one to be flawed or misleading. Their conclusion was both clear and well-supported: “Endtidal carbon dioxide measurement is at present perhaps the most reliable means under all circumstances of determining proper tube position and should be employed routinely whenever possible.

In July, 1985 the combined Anesthesia Departments of the Harvard Medical School hospitals adopted their “Standards for Minimal Monitoring during Anesthesia,” and in August, 1986 published them in the Journal of the American Medical Association. These standards stated “Monitoring end-tidal C02 is an emerging standard and is strongly preferred.” What did the authors of these standards mean when they used the word “emerging?” A subsequent discussion by Eichhorn et. al .3 of how the-se standards were conceived, gestated, and delivered strongly suggests that they intended capnography to be a standard as soon as possible. Even though they took into account the expense of universal installation of these devices they say, “This need for the earliest possible warning of adverse events led to mandating genuinely continuous monitoring’ Later in the discussion they hedged their position by saying, “there was intense debate about whether to mandate one or both of these devices (oximeters and capnometers) … the emphasis was on behavior and attitudes rather than technology.” Yet two sentences later they admit that some sort of alarm device was necessary to monitor for disconnection. Criticism of the group of Harvard anesthesiologists who are truly among the small band of founders of the contemporary patient safety movement is not intended. This analysis is offered merely to illustrate how hard it was to admit that machines can do a better job than even the most conscientious and vigilant physician, in some circumstances.

Even though the ASA had rejected the idea of formal published standards ten years earlier, it reconstituted the Standards of Care Committee in October, 1985 and one year later the House of Delegates approved a set of standards which stated “end-tidal C02 analysis, in use from the time of endotracheal tube placement, is encouraged.” In the preamble to these standards one finds the following statement. “The standards maybe exceeded at any time based on the judgement of the responsible anesthesiologist ” As is seen below, it seems that the chief of anesthesiology involved in this case had made just such a judgement.

Capno-History

There was also some informal information available about capnography to all anesthesiologists practicing in the United States during 1986 and 1987. An example can be found in the July, 1986 issue of the ASA Newsletter. Dr. Erwin Lear, the Editor, took space on the front page to discuss whether, now that oximeters were available, in-line oxygen monitors could be eliminated. He said, “factors that lead to hypoxia other than oxygen source failure are best detected not only with an oximeter but also an end-tidal carbon dioxide monitor ”

If one accepts that in early 1987 there was a de facto standard requiring capnography, what should have been the response of hospitals and how soon should they have bought the equipment? Again one must look at the available history. In the December, 1986 issue of this APSF Newsletter Dr. Ralph Epstein described how, in November, 1985 the chiefs of anesthesiology in 13 northern Connecticut hospitals agreed to a uniform policy for oxygenation and C02 monitoring. The minutes of these meetings were routinely sent to the chief executive officers of the member hospitals. He concludes by saying, “There is now a consensus among the anesthesiology chiefs that the action one year ago has significantly increased their ability to convince their respective hospitals of the importance of such equipment for patient safety.”

In the September, 1987 issue of the APSF Newsletter, Mr. William Cass, Director of Risk Management for the Joint Underwriting Association (JUA) of Massachusetts authored an article on strategies by which anesthesiologists could convince their hospitals to buy monitoring equipment.

In the current New Jersey Standards for Hospital Facilities, with which hospitals must comply on pain of losing their licenses, one finds the following in the section on anesthesia supplies and equipment; patient monitoring: “End-tidal carbon dioxide monitoring shall be performed continuously on all patients receiving general anesthesia.” Hospitals were given six months to comply from the date of publication of these regulations.

In his testimony, the Chairman of the Anesthesia Department where this adverse outcome occurred, displayed documentary evidence dated December, 1986 or January, 1987 of a procurement request to the hospital for capnographs. In his requisition he stated that if the monitors were not provided, the hospital would fail to meet the national standard of care. He also said that the monitors were to be fully operational by July, 1987. There can be no doubt that his actions strongly suggest his belief that capnography was the standard of care. However, the hospital argued that at the time, his statement concerning standards lacked an adequate factual basis.

Are hospitals held to the same standards as physicians? In previously litigated malpractice cases, courts have defined the “standard of care” as the course of action that a reasonably prudent (professional) with the defendant’s specialty would have taken under the same or similar circumstances. Other courts have applied the same criteria to the behavior of hospitals and also, as for physicians, have rejected the ‘locality rule’ in favor of a national standard.

In this case, the hospital contended that the plaintiff’s expert gave no testimony as to the number of hospitals having capnometers in place in November, 1987. There is little information available pertinent to this contention. The expert said that at the time of the incident he knew of four tertiary care hospitals, and also his own, that had installed capnometers. This incident occurred in a tertiary care hospital. Some tangential evidence is the finding by the JUA of Massachusetts that within six months of the signing of a Risk Management Premium Discount Agreement in July, 1987 (through which the use of oximeters and capnometers was mandatory) 97 percent of their insured Massachusetts’ anesthesiology members had installed both devices. There seems in all of this to be a relatively common thread of about a six month hiatus between the adoption of a standard and the installation of the device

The hospital also argued (without legal citations to support the argument) that widespread mandated practices are necessary to establish a standard of care. However, the plaintiffs cited a case in which a standard of due care embodied what a reasonably prudent hospital would do and hence care and foresight exceeding the minimum required by law or mandatory professional regulation may be necessary to meet that standard.

The jury agreed with these arguments, and the Court of Appeals affirmed their decision. There was a judgment against the hospital and a $4.5 million award to the plaintiff.

Reported by Dr. Gerald Zeitlin, Senior Staff Anesthesiologist, Lahey Clinic, Burlington, MA and a member of the APSF Newsletter Editorial Board. He wishes to acknowledge the assistance of Mr. Edward Brennan, Counsel to the Massachusetts Society of Anesthesiologists and Mr.

William Cass, Head of Risk Management at the Joint Underwriters Association of Massachusetts.

References

1. Eddy DM. Designing a practice policy. Standards, guidelines, and options. JAMA. 1990; 263:3077

2. Birmingham PK, Cheney FW, Ward RJ. Esophageal intubation: a review of detection techniques. Anesthesiology. 1986; 65:886

3. Eichhorn JH, Cooper JB, Cullen DJ, Gessner JS, Holzman RS, Maier WR, Philip JH. Anesthesia Practice Standards at Harvard: A Review. 1. Clin. Anesth. 1988; 1:55