Implementing OBA Regulations a Complex, Difficult Process

Ervin Moss, MD

New Jersey Example Illustrates What It Can Take to Make Office Anesthesia Safer

Much to the surprise of many, as of February 2000, regulations for office-based anesthesia (OBA) have failed to materialize in but a handful of the 50 states. Despite numerous reports of office deaths and of patient injuries due to doctor error and medication errors, few states have addressed the increasing volume and variety of surgery being performed in physicians’ offices.

Texas and Florida have proposed regulations that are pending while California basically requires that an office surgical facility be accredited by one of the three organizations (one of which is the JCAHO) now in the business of accrediting these facilities. New Jersey had regulations in place as of June 1998, but has failed to close the “alternate credentialing” loophole which would have the state’s Board of Medical Examiners credential physicians who do not have the otherwise required hospital privileges. An outsourcing of the credentialing mechanism is under consideration.

Obstructed Path

The pathway to passage of effective OBA regulations is strewn with numerous obstacles. Patient safety and the saving of lives and prevention of injury does not impress those powerful self-interest groups who see regulations as a threat to their financial bottom line. In no other venue in which surgery and anesthesia are practiced is there a lack of regulation or legislation. Yet, there are those who want the office, the most dangerous location for surgery and anesthesia, exempt from regulation.

The driving force, as it was in New Jersey, to establish regulations or encourage relevant legislation should be anesthesiologists. The rewards in terms of patient safety for their efforts are many. Regulations will mandate the latest in monitoring, up-to-date anesthesia machines, competent support staff, credentialed surgeons, preventative maintenance of equipment, and a methodology to collect data. This should also decrease malpractice exposure and should provide the anesthesiologist a physical plant, supported by protocols, that is fully equivalent to anything in the surgicenter and hospital settings.

There are two pathways to accomplish governmental mandated standards for office surgery and anesthesia. The first and most difficult is through legislation. A bill must be drafted by a state assemblyman/representative or senator addressing the issue. Co-sponsors must be signed on, and the bill must then work its way through committee meetings and hearings. The process is long and difficult. Behind the scenes, the “politics of patient safety” is in action – and not always in the patient’s interest.

An example of failure through legislation is New York State’s attempt at legislating safety. Despite the support of the powerful Senator Ray Goodman, legislation fell by the wayside under the intensive lobbying by many groups, including the Medical Society of New York, and individuals. Even the fallback position of settling for data collection failed. Most likely, New York will use guidelines which lack the force of law and lack that paragraph found in law which speaks to violation of the rules and resulting penalties that can be enforced.

Regulation vs. Legislation

The easier route to implementation of mandatory OBA safety systems is through state regulations. State agencies such as the Department of Health, the various Boards including Medical and Nursing, and even the Gambling Commission can all develop and pass regulations without requiring input or support from state legislators. The regulations are drawn up by committees appointed by the involved regulatory body and yield a draft document that is published in the state register or equivalent publication with an open comment period of usually 30 days. When demanded, public hearings are held but it is the board of the involved regulatory agency that votes on passage of the regulations with or without amendments or changes, based on testimony and written comments.

In most states, the Senate has an Oversite Committee which reviews regulations and to which appeals can be presented by those opposed to or in conflict with the regulations. This Committee has the power to overturn regulations passed and implemented by the lesser agencies and it was to this Committee that the New Jersey CRNAs via their lawyer/lobbyist appealed for the overturning of our office regulations. Testimony by anesthesiologists who had been made aware of the appeal and were present successfully responded to the charges made by the CRNAs and the regulations were left intact. The consequent lawsuit is now in the Court of Appeals.

Tactics for Action

It would be difficult to outline here all the tactics that must be used to get regulatory agencies involved and willing to act on what we perceive as a public threat, but which they or others might see as only a minor problem. First, anesthesia practitioners must conclude that office anesthesia and surgery is a threat to life and limb in their home state. This certainly was true in New Jersey! Then, what is desired for inclusion in the regulation must be defined. Anticipating the need for compromise, consider including a few “give aways” as later bargaining chips that are not crucial to the underlying purpose and always be prepared that the state may want something in return. In our case, it was the mandatory reporting requirement included in the hospital and surgicenter regulations by the Department of Health and in the Office Regulations by the Board of Medical Examiners.

Persevere; be prepared to face constant delays and long lapses in time between committee meetings, revisions of drafts, and even changes of state administration requiring starting all over again from the beginning. At the appropriate time, possibly years into the process, use the news media. Collect the reports of deaths and injury and use each case as a chisel to break down the facade that surrounds the bureaucracy. Always remember that your objective is to protect patients from injury and death and that the bureaucracy must be reminded constantly that they are there to serve the people while your motivation is not dollars but patient safety ñ actual human lives!

In conclusion, the final passage of the New Jersey Regulations, 14 years after the first office death of a 16-year-old was reported to the Board of Medical Examiners (BME) in writing, was the result of a circumstance no one could have predicted. One member of the BME, a plastic surgeon, who served on the OBA Committee himself had an office death. That, combined with two deaths in one office of a dermatologist, pushed the Board to act. As in many situations, it takes death to awaken those with the power to act. Hopefully your efforts to establish OBA patient safety regulations in your state can be achieved without further human sacrifice!

Dr. Moss is Executive Medical Director of the New Jersey Society of Anesthesiologists and a long-time activist promoting enhanced anesthesia patient safety through regulations.