Volume 11, No. 3 • Fall 1996

The New Jersey Experience: Mandatory Reporting Mechanism

Ervin Moss, M.D.

A detailed article appeared in the June, 1989, APSF Newsletter outlining the New Jersey Anesthesia Regulations adopted on January 23, 1989. Included in the Regulation were five unusual requirements: (1) the Chairman of Anesthesia Departments was required to be Board Certified (with the exception of two Chairmen who were Fellows in the American College by exam prior to 1982), (2) the regulation mandated the replacement of all obsolete anesthesia machines, as defined in the Regulation, within six months. Approximately 250 of the 500 machines in use in New Jersey at that time were replaced, (3) it required the use of oximetry, end tidal CO2 monitors, and temperature monitoring. It required that operations cease to be performed in an operating room in which a monitor was disabled. As a result, back-up monitors were purchased, (4) it required equipment servicing and preventive maintenance be performed by factory authorized personnel. If other companies were used, the Chief of Anesthesia became responsible for verifying the credentials of the servicemen, (5) the Regulation provided for a Quality Assurance Program which included a reporting mechanism for anesthesia related mortality and morbidity. In 1996, New Jersey is the only state with this requirement.

The Regulation States:

“(c) The hospital shall notify the Division of Health Facilities Evaluation and Licensing, New Jersey State Department of Health by telephone at (609) 588-7727 or (800) 792-9770 within 24 hours, and in writing within 30 days, of all deaths in anesthetizing locations and unexpected intraoperative or postoperative events or outcomes related to anesthesia.

(d) The written report shall be submitted on the form entitled “Confidential Report of Anesthesia-Related Incident” (HFE-5), available from the Department of Health, and shall include:

i. All deaths in anesthetizing locations, except those in which the patient expired prior to administration of anesthesia, and

ii. All unexpected severe intraoperative or postoperative untoward events or outcomes related to anesthesia.

Records of such reports and telephone calls shall be made available only to Department of Health personnel for official purposes and, for each report, to the specific facility to which the report pertains.”

Although the New Jersey State Society of Anesthesiologists had lobbied for four years prior to 1989 for anesthesia regulations, including mandatory monitoring and machine replacement, it had not included the reporting mechanism in its proposals. The New Jersey State Department of Health, embarrassed by a lack of knowledge as to untoward anesthesia events in New Jersey hospitals, inserted the mandatory reporting clause. The NJSSA considered this a “give away” in order to achieve the entire package which we believed would result in increased patient safety, decreased malpractice exposure, and decreased malpractice premiums.

The NJSSA encouraged its membership to cooperate and report all untoward anesthesia related incidents. By 1992, 1,200 reports had been filed. Then in 1992, a Coalition of Consumers attempted to gain access to the confidential reports by having the Regulation amended to permit release of incident reports. The New Jersey State Department of Health published in the New Jersey Register, a request for comments on the appropriateness of the Coalition’s demands. One hundred percent of the 120 comments received were against release of the anesthesia reports. The Coalition did not pursue its demands and the issue has been dropped. Although New Jersey anesthesiologists were aware of the challenge, reports continued to flow until, by late 1995, 5,000 reports had been received.

The first 1,200 cases were analyzed, but a budget crisis in New Jersey resulted in the almost complete lay-off of inspectors and others who could analyze data. Although all reports are screened for significant incidents, the data is not providing the intended information at this time. It is hoped that the New Jersey State Department of Health staff is re-hired to not only analyze the reports, but to continue the yearly inspection of hospitals which were in addition to JCAHO inspection.

There has been little thought given to the impact on patient safety as a result of budget crises within state or local governments. In New Jersey, we have the Regulations in place, but unfortunately, we do not have the staff, as in 1989, to enforce the Regulations and analyze vital data collected. The anesthesia community in the state is now the driving force to maintain the momentum of improving patient safety and its adherence to the reporting requirements is evidence of its commitment.

Dr. Moss is a member of the Board of Directors, Anesthesia Patient Safety Foundation, and Executive Medical Director, New Jersey State Society of Anesthesiologists.