Volume 5, No. 1 • Spring 1990

New Jersey Continues as Center of Anesthesia Regulatory Activity

Ervin Moss, M.D.

Preliminary Follow-up on NJ Standards

The comprehensive and detailed New Jersey anesthesia practice standards have had a significant impact on anesthesia care since their adoption early in 1989. The grace period for M implementation of the regulations expired in August of last year. Significant questions had been raised in the state concerning whether there would be compliance with the mandates, especially by the deadline.

Although all the data has not yet been collected, it is the opinion of the New Jersey Department of Health, as well as Ohmeda and the North American Drager Corporation that adherence to standards regarding replacement of anesthesia machines not complying with the regulations exceeds 90%.

Drager has replaced 50 anesthesia machines in New Jersey and has been able to update 97% of the machines for which retrofitting to current standards was requested. Ohmeda reported replacement of I 8 I “obsolete” (not meeting the regulation,) machines in New Jersey as a consequence of the standards. Sales figures fix)m any other manufacturers are not available at this time. In the majority of institutions, only one to four machines were replaced, but in several hospitals as many as 11 machines were purchased, replacing the entire anesthesia department’s equipment.

Remembering that the New Jersey State Department of Health has now found compliance to be at the 90% level, the following summation of a survey taken through April 1989 indicates the weak points as of ton months ago.

Summary of Survey Completed April 1989 (717 Machines)

[The terms, “Current” and “Non-current” were used to describe those machines meeting or not meeting New Jersey standards.]

1 . 80% of hospitals responded to the survey.

2. 77% of the 717 machines failed to meet standards when the machines and the monitors were examined as a package

3 . 90% of noncurrent machines were in use with 10% in storage.

4 . 80% of current machines were used in the operating room while 50% of the noncurrent machines were also used in the operating rooms. The largest number of noncurrent anesthesia machines were found in labor and delivery rooms and cysto rooms.

5 . 92.3% of the 717 machines had an EKG monitor, the remainder without.

6. 90.2% of the 717 machines had an oxy8en monitor while 9.8% were without.

7. 5 1 % of the machines had a spirometer of some sort.

8 . 65. 1 % lacked a breathing system pressure monitor.

9 . Hospitals under 200 beds and over 500 beds had the greatest percent of current equipment with the larger number of noncurrent equipment found to be in hospitals from 200 to 500 beds.

10. 46.4% of the 717 machines were without endtidal PCO2 monitors’

11. 81.6% of 717 machines were equipped with pulse oximeters.

12. The oldest machine in use in New Jersey was manufacturered in 1950. One hospital had seven machines, some of which were manufactured in 1950, 1951 and 1952.

Twenty percent of the 100 institutions surveyed failed to respond to a questionnaire named by one anesthesia machine manufacture. The questionnaire was intended as a generic service, but some of the non-reponders had other brands of machines. In any case, the list of hospitals not responding was supplied to the State Department of Health by the New Jersey State Society of Anesthesiologists for priority inspections.

The State Department of Health Inspection Team has noted the replacement equipment in place, but there has been frequent failure to update conomitantly the associated policy and procedure manuals defining the standards.

In Massachusetts, downtime is permitted for disabled monitors to be repaired. In New Jersey, by contrast, the policy is to require back-up oximeters, oxygen sensors, and end-tidal C02 monitors to be available. Further, no anesthetic is to be administered, unless in life-threatening circumstances, when these monitors are not functioning. Such a policy statement is required in the department’s policy and procedure manual.

The most frequent questions asked by hospitals pertain to the endoscopy suites and the use of so-called “conscious sedation” where oximetry, blood pressure monitors and EKG monitoring are required, but anesthesia personnel are not. This exception for personnel was based on organized and active protests against the involvement of anesthesiologists in these areas.

Using the publicity surrounding deaths and complication arising from conscious sedation, the N.I.S.S.A. presented arguments for the need for anesthesia personnel during endoscopy when IV sedation is given. This was not supported by both major malpractice insurers in New Jersey based on lack of claims experience. However several hospitals have moved their endoscopy activities to the operating room suites with anesthesia staffing available.

Although only two chiefs of anesthesia departments protested the requirement for board certification, both were grandfathered by having passed the College examination before 1972. One board certified anesthesiologist has come forth to file a suit against a hospital who refused to replace the nonboard certified chief. As the only board certified anesthesiologist in that hospital, he is attempting to force the hospital to comply with the standard. Another major institution has a search committee actively looking for a board certified anesthesiologist to replace the present non-board certified chief.

More information will be relayed as it is forthcoming. The New Jersey experience is unique and is providing precedent – setting data that being observed widely in other states across the country.

Post Anesthesia Care Unit Standards Approved

On January 10, 1990, the New Jersey Department of Health announced the successful completion of the Licensure Reform Project, including standards for Post Anesthesia Care Units.

This project of establishing hospital standards for some 32 hospital areas included the anesthesia practice standards. These were given top priority and passed into regulation as of January 1, 1989. The remaining standards have been approved by the Health Care Administration Board of the New Jersey Department of Health. The standards will become operational on July 1, 1990. For the next five months, training sessions are planned so that both surveyors and the hospitals will be ready by the implementation date

The New Jersey State Society of Anesthesiologists Committee on P.A.C.U. standards, consisting of Drs. Gerald Shapiro, Sanford Klein and Ervin Moss, was represented at all meetings concerning the P.A.C.U. standards, as were representatives of P.A.C.U. and Critical Care nursing organizations. The standards were published in the New Jersey regulations for a thirty day period and al comments were answered by the state. The only change as a result of these comments was a suggestion by the N.I.S.S.A. that discharge criteria be clarified.

The P.A.C.U. standards required 1) EKG monitoring, 2) the use of pulse oximetry on each patient “unless such monitoring is not clinically feasible for the patient,” and 3) immediate access to end-tidal carbon dioxide monitoring.

The standards require that there be a physician director with overall responsibility for the post-anesthesia care unit and that the physician director may also be the director of the anesthesia services. It defines the credentials of the registered nurse staffing the P.A.C.U. and their training environments including Basic Life Support and Critical Care training.

The ratio of staff to patients was established to be at least two health care personnel, one of whom is a registered nurse and the other of whom is a licensed practical nurse or a physician, present whenever a patient is in the post-anesthesia care unit. Therefore if there is one patient in the P.A.C.U., a P.A.C.U. nurse and a support person would be present at all times. When there is more than one patient, there will be a ratio of at least one registered trained professional P.A.C.U. nurse for every three patients in the P.A.C.U.

The regulation mandates that a patient be accompanied to the P.A.C.U. by two individuals, one of whom, stationed at the patient’s head, shall be a member of the anesthesia team. It requires an oral report on the patient’s condition by a member of the anesthesia team upon admission to the P.A.C.U. It requires that a oral report of the anesthesia team shall stay with the patient in the P.A.C.U. at least until the patient’s vital signs, including blood pressure, pulse and respirations, are recorded.

The regulation defines the necessary documentation of the patient’s condition while in the unit by the nursing staff . Discharge shall be by discharge criteria, including the authority to discharge, which have been developed through the required written policies and procedures. Admission and discharge criteria are required in written policies and procedures that are reviewed annually, revised as needed, and implemented. Since the I.C.A.H.O. permits discharge by criteria, this wording would permit a department to write a protocol, for example, for discharge requiring a patient to be discharged only personally by an anesthesiologist.

Finally, the regulation requires that a P.A.C.U. shall be adjacent to or within the O.R. suite and likewise, the OB suite and that it be a restricted zone maintained as a dosed unit. Access to the restricted zone of the P.A.C.U. shall be through or past a control center It defines proper attire for P.A.C.U. staffs and others permitted access to the unit. It lists minimum equipment, educational program requirements, and Q.A. requirements.

For a copy of the complete regulation please write the New Jersey State Society of Anesthesiologists, Inc., 2 Princess Road, Lawrenceville, New Jersey 08648.

Dr. Moss, an APSF director, has been extremely active in the N.J.S.S.A. Standards Committee for some time.