Volume 11, No. 4 • Winter 1996

MD-Office Safety Regs Stalled in New Jersey

Ervin Moss, M.D.

Anesthesia Proposal follows office deaths

Despite a front page article on September 23, 1996, in New Jersey’s leading newspaper, The Newark Star Ledger, detailing the risks and deaths that had occurred in one doctor’s-office operating room, the state regulation titled “Surgical and Anesthesia Standards in Physicians Offices” is stalemated somewhere within the bureaucracy responsible for its publication in the New Jersey Register. The newspaper article was an effort to bring public pressure on those who have delayed implementation of safety regulations for doctors’ offices that perform surgical procedures under anesthesia.

The New Jersey State Society of Anesthesiologists (NJSSA) has been an advocate for patient safety for more than two decades despite being greatly outnumbered by special-interest groups opposed to any form of regulation of the office operating room. In 1977, an appeal was made by this author to the Medical Society of New Jersey (MSNJ) to support control of Valium used by non-anesthesiologists with often tragic results. Again in 1987, the same appeal went unheeded when Versed became the drug of choice for “sedation.” Anesthesiologists represent three percent of the MSNJ membership, while the endoscopists, the plastic surgeons, the gynecologists, the orthopedic surgeons, and others successfully opposed any regulations. Finally, the Joint Commission solved part of the problem by requiring conscious sedation standards and credentialing inside hospitals in the 1990’s.

New Jersey malpractice carriers were also approached to help in efforts to regulate the administration of anesthesia in offices through instituting surcharges on malpractice premiums of non-anesthesiologists administering “sedation” in offices. This was rejected with the comment that unless all insurance carriers agreed on the policy together, it would put the carrier surcharging for anesthesia by non-anesthesiologists at a disadvantage in the marketplace.

After five years of pressure by the NJSSA, the Hospital Anesthesia Regulations in New Jersry were passed in 1989. These regulations required replacement of obsolete anesthesia machines, adoption of monitoring standards (including end tidal CO2), a mandatory reporting mechanism for adverse events, PACU standards that included staffing minimums, maintenance requirements, etc. These regulations only applied to licensed hospitals and ambulatory care units. Although surgery and anesthesia in doctors’ offices was put on the table for consideration, it was not included in the regulations because the New Jersey Department of Health only had jurisdiction over licensed institutions, not doctors’ offices.

Offices “Off Limits”

In New Jersey, Certificates of Need (CON) are not required for a one-operating-room facility. The power to regulate this type of installation is in the hands of the New Jersey Board of Medical Examiners. In 1984, this author wrote to the Board warning about the dangers of anesthesia in the office setting following the death of a teenager. Again, an unsuccessful appeal was made to the MSNJ to support our efforts to regulate surgery and anesthesia in offices. Politics made this last bastion of physician practice, the office, off limits to any regulation.

For years, meetings have been held with the Board of Medical Examiners to develop regulations for doctors’ offices. The involved committee was made up of Board members, one of whom was a plastic surgeon who recently had an office complication in his plastic surgery office facility resulting in a patient death. Other members represented radiology, endoscopy, nurse anesthesia, gynecology, plastic surgery, the New Jersey Attorney General’s office, the MSNJ, the NJSSA, and related interested parties.

Most verbal in opposition to regulation of anesthesia in offices was the radiologist, despite the death in New Jersey of an 18-month-old during an MRI under rectal pentothal in an office. The radiologist first argued that monitors were not available and, when presented with MRI compatible monitoring equipment, still protested; so much so that radiology facilities were taken out of the regulations’ early drafts by the Board.

Each representative on this crucial committee had his own special interests with the exception of the anesthesiologists and the CRNAs, who recognized the need for regulation of these offices in which anesthesia was administered that were springing up all over the state.

The final draft of the regulations approved in August, 1996 by the Board includes a restriction that general anesthesia can only be administered by an anesthesiologist or by a CRNA under the supervision of an anesthesiologist. This was not part of the NJSSA recommendations. It was the conclusion of a Deputy Attorney General that in New Jersey CRNAs must practice in licensed hospitals and ambulatory care centers under the supervision of an anesthesiologist and that it would be logical that the same requirement be met in the least safe of all locations, the office operating room.

In the final draft regulations, “conscious sedation” in offices can be administered by CRNAs under the supervision of the operating surgeon who must be credentialed by a licensed hospital to administer conscious sedation. Anesthesiologists must also be credentialed by a licensed hospital in order to practice in an office. Numerous protests from those who only practice in offices delayed the regulations while an alternate credentialing pathway through the Board of Medical Examiners was developed.

In the proposed regulations, conscious sedation can also be monitored by an RN knowledgeable in monitoring who will be permitted to administer subsequent dosages of the drug under direct orders of the operating surgeon who must administer the initial dose.

Much of the substance of the regulations follows the 1989-1990 hospital and ambulatory care (more than two operating rooms) standards. Included is replacement of obsolete anesthesia machines, equipment maintenance requirements, monitoring including end tidal CO2 for general anesthesia, PACU standards, and a mandatory reporting mechanism for all deaths and untoward events.

Regulations Opposed

Opposition to the regulations recently came from New Jersey State Senator Gerald Cardinale, himself a dentist, who in The Star Ledger article stated, “Maybe this is evolving into a better set of rules, but it started as a power play to get procedures back into the domain of the hospitals and anesthesiologists.” He had been lobbied by the radiologist on the Committee to help stop the regulations. Dentistry in New Jersey is under the Board of Dentistry and a reliable source has advised this author that it is feared that new standards for administration of anesthesia might pressure the dentists to consider new rules which Senator Cardinale will oppose. Thus, political pressure is being exerted by dentists despite the fact that the proposed regulations do not apply to their practices. As part of political protocol, this author visited Senator Cardinale in his office to explain that the only motivation of the NJSSA is patient safety. It was also explained that the regulations would not drive up the cost of medicine–an argument which had been used as yet another delaying tactic.

The HMO Factor

At the time that office regulations were proposed in the late 1980’s and early 1990’s, HMO practice demands were not considered. It soon became obvious that HMOs would try to push surgical procedures out of hospitals to ambulatory care facilities and to offices and that the need to develop standards was urgent in order to provide an equally safe venue for the administration of anesthesia and for surgical procedures. Standards for the surgical procedures in the early drafts, incidentally, were not included due to political pressure by the surgical specialties. The most important relevant positive statement in the final draft requires a surgeon to be credentialed in a licensed facility to do a procedure that he performs in his office. In November 1996, HMO Blue, a managed care product of New Jersey Blue Shield, advised its surgeons that they would receive a 15 percent bonus payment if specific procedures were performed in designated ambulatory care centers or participating doctors’ offices–as opposed to in presumedly more expensive hospitals. All ambulatory care centers in New Jersey with more than one operating room are under the regulation of the New Jersey Department of Health. As noted, with few exceptions, one-operating-room offices are not regulated. Eye centers with one operating room, for example, require Medicare approval and once it is obtained, inspections are performed by the New Jersey Department of Health. However, patient safety appears at risk for negative impact by budget cuts that have decimated inspection staffs in New Jersey. Nevertheless, HMO Blue will encourage office procedures by offering a 15 percent bonus surgical payment as of January 1, 1997.

The unregulated one-operating-room office was used by an HMO in a small North Jersey community as a proposed alternative site for surgery to help pressure the local hospital anesthesia staff to accept this HMO’s fees. Same-day-surgery patients were mandated to use only an unregulated one-operating-room office with denial of payment if the hospital was used. Under this pressure, the anesthesia department in the local hospital accepted the deeply discounted HMO rates.

“An office with an operating room is no longer an office” was the protest made by an inner city hospital administrator when offices were excluded from the 1989 Regulations for Hospitals and Ambulatory Care Centers. It is as true today. “The safest place to get anything done is in a hospital,” said Dr. Charles Cote’ of Chicago’s Children’s Hospital, who was interviewed by The Star Ledger. Dr. Cote had included the New Jersey death of the 18-month-old in an MRI office in his statistics which, at the time, covered 85 children dead from conscious sedation. Thirty were dental cases and of the remaining 55, 18 were in MRI units. These statistics were presented to the New Jersey Board of Medical Examiners, which then appeared to have no choice but to include radiology back in the final draft for the office standards. Rather than accept this inclusion, the radiologist on the committee has brought pressure in an attempt to stop the regulations through meetings with the NJ Commissioners of Insurance and State Senator Cardinale.

On Sunday, November 17, 1996, The Star Ledger reported on the closing of two gynecologists’ offices and ordered them back for retraining. This action stems from a patient death in 1991 after an office surgical procedure. The patient “failed to wake up from anesthesia;” the anesthetic was administered by a CRNA in an office setting. This particular death was unknown to this author and was not included in the list given to The Star Ledger for the September expos.

Investigations reported revealed as many as 27 procedures per day were performed by the gynecologist and CRNA with an unattended recovery area, no crash cart, unlicensed aides, no one trained in ACLS, and absence of proper protocols. Ironically, the charges in this case were written by the same Attorney General who sat on a committee of the Board of Medical Examiners in 1982-1984 with this author. This committee’s intended purpose was to define the scope of practice of CRNAs. The Committee failed to produce a document and was dissolved. The newspaper article, written by Gail Scott, reflected the knowledge gained from preparing the September article by mentioning the quest by the NJSSA to establish standards for offices, the impact of HMO cost-cutting measures, and dangers in office surgery and anesthesia.

While death and injury are obvious results from unsafe office practices, the rarely identified complication of infection usually goes unrecognized. This author visited an outpatient gynecology facility on behalf of the New Jersey Department of Health to find the same single IV bag and tubing being used with only the needle being changed between 12 consecutive procedures by the CRNA. The same Pentothal syringe was used multiple times also. Incidentally, a CRNA organization has already written to The Star Ledger complaining that the draft regulation is an attempt to “put them out of business” because in the six cases reported, four involved CRNAs.

In summary, it is naive to believe that patient safety is a subject with such universal appeal and agreement that it will not be challenged. There are a multitude of special interest groups that have actively lobbied and are lobbying against the entire regulation involving surgery and anesthesia in doctors’ offices or against specific sections. Their motivations can seem to be protective–of their turf or pocketbooks.

The American Society of Anesthesiologists has as its motto “Vigilance.” The NJSSA suggests that “Perseverance” be added–for without perseverance, patient safety can become secondary to financial pressures on and by those such as HMO’s and those with self-interests who strongly oppose any change in the status quo, despite clear dangers to patients.

Dr. Moss, Executive Medical Director of the New Jersey State Society of Anesthesiologists, is a member of the Board of Directors of the APSF.