Practice guidelines and liability implications

by
F. Dean Griffen, MD, FACS,Shreveport, LA, and
Josef E. Fischer, MD, FACS,Cincinnati, OH

The principal goal of practice guidelines should be improved patient care. Efficiency and efficacy are important, but the physician has always been a patient advocate. The principal tenet of the American College of Surgeons is better care of the patient. Thus, any practice guidelines should have improved patient care as the guiding principle. The following, therefore, are our thoughts regarding practice guidelines and their potential liability implications.

What are practice guidelines?

Practice guidelines are statements containing suggestions with respect to the components, nature, and pari passu quality of care. They may be broad in outline with general statements concerning the type or nature of investigations, tests, and examinations that are appropriate under the circumstances of the diagnosis of the family of diseases that is being investigated by the physician. Or they may be very specific. Also, there are the guidelines for referral. Usually promulgated by managed care organizations, especially in circumstances in which there may be a significant monetary incentive to the physician, or certainly to the managed care organization, not to refer and not to use investigational tests, such guidelines are an attempt to define the minimum quantity of care that is considered appropriate for a given diagnosis.

Practice guidelines may be of various types:

MD-written guidelines.

Data-based. Examples include guidelines written as a result of practice audits or, more recently, outcome analysis.

Consensus. Usually the result of a group of physicians with special interests in the area writing guidelines based on experience.

Indication-based. Examples include those in which specialists in a related area have written guidelines for surgery. An example is guidelines for cholecystectomy written by gastroenterologists.

Non-MD-written guidelines.

Guidelines written by nurses, pharmacists, and administrators with ``physician input."

Guidelines which are population-based. Examples include population-based care parameters. These guidelines may not be ideal for a given patient, but represent the most efficient use of resources for a given population.

Why are guidelines written?

Ideally, guidelines are written to enhance the quality of care patients receive. This is the primary purpose when guidelines are written by physician groups, organizations, or societies. Hospital staff guidelines are often written to help hospitals comply with the rules, regulations, and standards imposed by certifying agencies. Coincidentally, some hospital staff guidelines enhance the quality of care and help achieve cost-containment as well. However, many practice guidelines are written by managed care organizations. Managed care organizations generate guidelines, it appears, to preserve a certain minimal acceptable standard of care while controlling costs by prohibiting ``excessive care" (more expensive care). Diagnostic, therapeutic, and referral options may all be limited with practice guidelines.

Some states, especially Maine, have legislated guidelines designed to reduce health care costs by eliminating defensive medicine and to protect doctors from fallacious litigation. These guidelines have the full force of state law and, theoretically, protect the physician from the risk of litigation when a plaintiff's expert witness touts any other (excessive) standard.

In 1989, business, labor, and health care interests in the state of Maine became concerned that the cost of health care delivery was increasing because physicians were ordering unnecessary tests, procedures, and consultations, the purpose of which was to establish an unassailable record as protection in the event that an undesirable outcome would later lead to litigation. A coalition representing the interest groups was formed. Four highly litigious areas were defined to be used as a pilot group—anesthesiology, emergency medicine, ob/gyn, and radiology. Drawing liberally from guidelines already established by several national specialty organizations, including the American College of Obstetricians and Gynecologists and the American Society of Anesthesiologists, parameters were established resulting in legislation that had wide physician acceptance. The resulting laws established practice guidelines, which are now used to define the standard of care without the need for accompanying medical expert testimony.

To prevent the guidelines from being used against physicians, their introduction by the plaintiff is prohibited. Maine law further requires all malpractice cases to be reviewed by pretrial screening panels that may use these guidelines while determining the merits of a claim. Problems with data collection and analysis have prevented assessment of the effect of these laws on medical costs. As of August 1995, there was no instance in which the guidelines were used in court during the defense of a physician during litigation.*

Who writes guidelines?

Given the variety of guidelines that have been promulgated, it should not be surprising that a variety of individuals have participated in the writing of practice standards. It would be optimal if only physicians wrote guidelines. However, as many physicians have learned, trying to write guidelines for any given disease state or given diagnosis is highly complicated. The problem is that physicians know too much and are well aware of the vagaries of different cases that may interfere with the ability to write a single, succinct set of guidelines for a given diagnosis. Thus, many organizations, such as the American College of Surgeons, have tended to avoid writing guidelines because of the complexity of medical care and the realization that one is unable to accurately foresee the different combinations and permutations in a given situation. Better, they argue, not to write anything than to write something that is inaccurate.

No such compunctions seem to pervade the minds of those in nonsurgical specialties, who apparently feel perfectly free to write guidelines concerning the surgical treatment of cholelithiasis, for example. One might question why an individual who has never been inside the operating room, has never had his/her hand around a gallbladder or a complicated common duct, has never seen some of the difficulties in the vascular supply to the gallbladder, or has never seen a laparoscopic cholecystectomy, feels justified and comfortable in his/her ability to write guidelines for the surgical treatment of cholelithiasis. Hubris, however, has never been in short supply in our profession. Some of these individuals clearly may not have the appropriate education, skill, training, or experience to justify their writings.

It is commonly said that physicians write the guidelines for managed care organizations. It is probably much more likely that physicians have some input to such guidelines, the majority of input coming instead from nurses, administrators, PhDs in related fields, or perhaps even lay people. One cannot be sure. While it is probably true that appropriate lip service is paid to physicians' input, as we all know, when one is handed a set of guidelines and asked to review it in 48 hours or less, enthusiasm and contribution will be minimal.

By far the greatest danger in our view is the practice standards for the inhospital setting. The various QA (quality assurance), CQI (continuous quality improvement), or TQM (total quality management) proposals (the latest rubric in alphabet soup in the Joint Commission on the Accreditation of Healthcare Organizations manuals), suggest a whole series of committees that deal with patient care. These are, in fact, the latest iteration of the old practice audit, abandoned years ago because of demonstrated lack of effectiveness. These committees consist largely of nurses, administrators, and pharmacists, with token physicians who may or may not have the time, interest, or inclination to attend the meetings—let alone participate in the writing of guidelines. When these guidelines are finally promulgated, they are usually presented to the medical executive committee in a mountain of paper. Thus, they may be passed without really having been read or thought about.

To be sure, there are happy exceptions to such a sorry litany. Certain surgical organizations, such as the Society for Surgery of the Alimentary Tract, have written sensible, broad outlines of surgical care, establishing a standard of practice with broad brush strokes. These guidelines were written by a group of volunteer surgeons with recognized interests and expertise in the areas that they dealt with. Guidelines were written by consensus with an eye toward potential professional liability implications if the guidelines were made too specific. These guidelines are defensible and give ample opportunity for deviations based on the circumstances. However, such guidelines are by far the minority.

Who reads and uses the guidelines?

The most certain statement concerning such guidelines is that physicians do not use them. This is ironic, since guidelines are specifically intended for physicians. Would a surgeon treating cholelithiasis for the 259th time sit down and read the practice standards for the treatment of cholelithiasis?

However, other organizations and individuals do read such guidelines. These include managed care organizations, insurance companies, and utilization reviewers who attempt to define the appropriateness of care. Their rule appears to be that if something is expensive and is possibly not always necessary for the standard of care, or if the situation can be bent somewhat to make it not necessary for the standard of care, it will be disallowed.

Their decisions sometimes relate to the rules of population-based care, a concept physicians have difficulty understanding. To paraphrase: the individual patient may not be as important from the overall standpoint of expense as the entire population. Population-based medical care takes into account the fact that in the treatment of a particular patient, what is being proposed may not be ideal. However, given the limited resources available to the entire population, the argument goes, the population is much better served by denying to an individual certain services that are expensive, so that more services, deemed more cost-effective to the entire population, remain available to the whole group. This is in fact the ``R" word (rationing) put in a different guise. It recognizes that medical resources are limited and that we will have to make financially-based choices. For that, it should be applauded.

Unfortunate, however, is the high-sounding rhetoric that accompanies denial of care to an individual patient who is in need. Physicians, it need not be pointed out, have never been trained in ``population-based medical care." What the physician has traditionally done is to be each patient's advocate. Thus, the concept of denying care to a specific patient for some real or imagined greater societal good is completely foreign to physicians. The American College of Surgeons has always been the patient's advocate, and thus, if confronted with the concept of population-based medical care, Franklin Hayes Martin (founder of the college) might have great difficulty with it.

There is another group that reads practice guidelines, and reads them very intently now that litigation has become computer-based—attorneys. In fact, as the Internet widens, practice guidelines will be available to just about anybody. It is perhaps hospital practice standards that may prove most damaging in a case of professional liability litigation. How embarrassing and damaging to a physician and/or surgeon on a hospital staff who has never read the hospital's practice guidelines to find that practices that have served in good stead for 30 years are no longer considered the standard of care and may be used against that particular individual in a malpractice case. Far-fetched? Not at all, and cases such as this are beginning to surface.

Managed care guidelines

Guidelines for managed care organizations thus far have dealt mostly with excessive use of resources rather than ideal patient care. Implicit in these guidelines is the recognition that while such guidelines may not give absolute exemplary care in all instances, the care given is adequate. Some examples follow:

Denial of colonoscopy for lower gastrointestinal bleeding. Air contrast barium enema may detect most polyps, but not mucosal lesions.

Denial of early diagnosis of stroke by neurological specialists. This delay prevents the use of TPA in thrombotic strokes, with demonstrated recovery.

While these guidelines are cost-effective, they have not, for the most part, withstood the test of outcome analysis.

Proposals

The following are proposals for preventing practice guidelines being used against physicians and surgeons in a professional liability setting:

That such guidelines, if they must be written, be written by physicians.

That hospital guidelines, if written, be written for that hospital with its resources, rather than the resources of a larger institution. Put another way, smaller hospitals copying larger hospitals' guidelines may demand a standard of care that they are unable to achieve.

3. That such guidelines be as broad and as general as possible, aiming toward the standard of care.

4. That such guidelines, when written, take into account the variations not only in practice pattern but in disease presentation, especially in patients who are on various drugs such as steroids, and in an older-age population in whom the response to a given disease may not be as usual or as obvious as in a younger population.

5. That such guidelines be written to encompass a variety of practices of individual physicians in a different area, as well as geographic variations between regions.

That if guidelines must be written in a hospital, they be written by a committee consisting of nurses, pharmacists, administrators, and medical liability defense lawyers, and that physician participation be realistic and appropriate.

7. That if such guidelines come before medical executive committees, these guidelines not be looked upon as a ``done deal" but that they be carefully scrutinized and, if inappropriate, sent back to the committee.

8. That if guidelines must be written by organizations, the organization cover as many circumstances as possible. The guidelines should emphasize variations in disease presentation in different age groups and individuals with various concurrent diseases.

9. That, above all, guidelines be written in such a way that it is quite apparent to all writing them that they may be used against physicians by plaintiff litigation attorneys.

10. That if practice guidelines are written for the purpose of managing the care of the patient, care be taken so that the patient will receive the best possible treatment under a variety of circumstances. Those physicians writing guidelines should make certain that population-based medicine, which we believe is a flawed concept, gives way to the care and advocacy of the individual patient, which is the strength of medicine and the central issue for the American College of Surgeons.

11. That if managed care guidelines become available prior to contractual agreement signing, surgeons should protect themselves by appropriate disclaimers so that treatment of patients be appropriately individualized.

12. That outcome data, where available, be used to write guidelines.

13. That if guidelines are written, all staff physicians should read them and acknowledge that they have done so.

Summary

It should be clear that the authors of this article are not enamored of practice guidelines, thinking them of much more potential harm than good. On the other hand, if practice guidelines are deemed essential, then they must be written with the goal of quality patient care advocacy and with an eye toward the possible damage they may do.

*See: Morton, J: The Maine demonstration project: Using practice parameters as an affirmative defense. Bull Am Coll Surg, 80(8):30-33, 1995.

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Dr. Fischer is the Christian R. Holmes Professor and chairman, department of surgery, University of Cincinnati (OH) Medical Center.

Dr. Griffen is clinical professor of surgery, LSU Medical Center, Shreveport, LA.

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Bulletin of the American College of Surgeons
Vol. 82, No. 3, March 1997

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