Alleged OBA Benefits May Overshadow Great Risks; FDA First, Then ASA Regulations Recommended

Istrati Kupeli, MD

To the Editor

The Spring 2000 APSF Newsletter refers to important issues concerning Office-Based Anesthesia that neither ASA nor the practicing members of our society fully appreciate. After a multiyear evolutionary process based on sound clinical and technological principles, anesthesia safety and quality reached an enviable high level. OBA by focusing directly on economics trespasses such principles and is navigating a course in uncharted waters.

Quoting studies on the cost of hernia repair in an office vs. hospital setting is a poor and incomplete example of comparison. It is not clear whether the cost of regulatory and quality standards imposed on hospitals have been considered in such analysis. However, viewed in the context of quality and safety, such costs may be justifiable. Should similar regulations and standards be imposed on an office-based practice, the cost differential most likely will decrease, making it comparable to that seen at the surgical day center today. It is interesting to note that the guidelines drafted by the ASA for OBA are identical to those for the surgical day centers thus creating an unnecessary duplication of standards for such practice.

A key element for the promotion of OBA is the flexibility in scheduling procedures, more efficient time utilization and convenience for patients. The liberal scheduling flexibility is intertwined with economic benefits that frequently have the tendency to dissociate quality and safety. The principal beneficiary of these economic benefits is the surgeon. Professional fees blended with “facility fee” provide a strong incentive to increase volume to the maximum. Consequently, tailored for speed and convenience, anesthesia services are dictated by surgeons who frequently have minimal, at best, knowledge of anesthetic indications and safety. In this instance, the choice of anesthesia provider depends not on qualifications but on compliance with the surgeon’s whims. This is the most dangerous aspect of OBA and must not be taken lightly. One article lists 13 officially known patients, victims of office-based practice. Under these circumstances anesthesia practitioners who have a bad patient outcome can be easily trapped in a legal black hole with no way out for the rest of their professional life.

Comparison to Unsafe Drugs

Regardless the cost of production, the FDA without hesitation withdraws from the market any drug that is even remotely suspected in patient mortality. The University of Pennsylvania took similar action when gene therapy ended with a fatality. ASA, on the other hand, while officially aware of mortality after OBA, condones such practice and pacifies its advocates by taking refuge in the existing day surgery standards.

Today in the absence of federal and state regulations, office-based surgery is performed with increasing frequency by a variety of non-surgeon “surgeons” who lack skills and training. Frequently they underestimate the risks of anesthesia and once in trouble, they spread their liability to the anesthesia provider (qualified or not) exposing the patient to unnecessary and often lethal danger. Before undertaking any effort in drafting standards, ASA should actively pursue federal and state authorities to regulate office-based practices first by designing standards for safety and practitioner qualifications. Once such regulations are in place, ASA should go forward in drafting professional, technical and logistical standards for OBA. The presented standards for OBA by the ASA are not enforceable and as such have minimal value at best.

Finally, one should consider the effect of OBA on anesthesia manpower in general. Creation of another subspecialty in anesthesia will dilute the existing manpower from established healthcare entities. Running in every direction, anesthesiologists created a niche demand that the future supply of well-trained and qualified individuals may not be able to meet. Paramedical anesthesia practitioners, practicing unsupervised may partly fill the demand thus creating political implications with medical ramifications.

Istrati Kupeli, MD
Wellesley Hills, MA