The publication on February 21, 1989 of Anesthesia Standards as New Jersey state regulations was the culmination of efforts on the part of the New Jersey State Society of Anesthesiologists that started in December, 1984.
Data showing anesthesia machines dating back to the early 1950’s in use in New Jersey and clinician’s frustration by inspections from the New Jersey Department of Health that focused on trivia precipitated the original ideas. The proposals targeted mandatory replacement of antiquated machines and inspections by the Department of Health including the enforcement of meaningful standards concerning patient monitoring anesthesia machines and their servicing, documentation of daily inspections, and who can administer an anesthetic in New Jersey.
Insurance First Focus
In early 1985, the Risk Management Committee of the Medical Society of New Jersey, representatives of the New Jersey Hospital Association, and representatives of the two major insurers of anesthesiologists in New Jersey met jointly. The initial intention was to put into the malpractice insurance policy language the standards the New Jersey State Society of Anesthesiologists had formulated, with enforcement penalties. The two insurers were reluctant to include standards in policy language and felt that New Jersey’s insurance laws would not permit such standards. The New Jersey Hospital Association remained s4ent and noncommittal.
The N.J.S.S.A. next approached the Commissioner of Health, who responded positively but there were administrative delays. Suggestions of trying to interest newspapers in the article, “State Fails to Act on Anesthesia Safety Standards” brought three representative from the State Department of Health to see Dr. Moss (chairman of the N.I.S.S.A.’s Committee on Standards) to be educated on the dangers of outdated machines and the value of the new technology available, such as capnography and oximetry.
In 1985, the new Commissioner of Health recognized the value of the intent of the N.I.S.S.A. and assigned staff to work with the N.I.S.S.A. to develop standards in anesthesia. This paralleled the licensure Reform project of 1988, which was involved in the general development of new standards in 32 hospital departments including anesthesia. A series of anesthetic mishaps in a New Jersey hospital resulted in negative publicity for the hospital and its anesthesia department. The state government was put in the embarrassing position of admitting its lack of knowledge as to anesthesia mortality and morbidity within the state. As a result, the central reporting mechanism in the standard was demanded by the state and that point was accepted by the N.I.S.S.A. against the protests of the New Jersey Hospital Association and many anesthesiologists.
A committee of the N.I.S.S.A. and representatives of New Jersey C.R.N.A:s invited by the state as anesthesia providers met with the Department of Health frequently over a two-year period. Interestingly, the standard that all chiefs of anesthesia departments be board certified in anesthesiology was not on the N.J.S.S.A:s agenda, but put into the regulation by state staff.
There was no lobbying of state senators or assemblymen. The New Jersey Hospital Association attempted to delay the anesthesia standard by protesting its removal from the Licensure Reform Project and its priority status of enactment separately and earlier than the U regulation. The Association also protested the cost of equipping the O.R ”s with new machines and monitors. However, at the final vote of the Board of the New Jersey Health Department (HCAB) there was unanimous approval of the regulation. The Hospital Association remained silent and voted for the regulation.
The Board (HCAB) questioned the failure to address standards for five-standing same-day-surgery units, women’s clinic facilities, and recovery rooms. They also suggested the need for anesthesia standards in doctor’s offices (e.g. of plastic surgeons and ophthalmologists) in which anesthesia is administered. All of these issues are now being addressed by N.I.S.S.A. and the Department of Health. The issues of endoscopists and I.V. sedation is addressed in the requirement for monitoring including oximetry and the credentialing of those who administer I.V. sedation. The N.I.S.S.A. did not suggest anesthesia personnel in attendance during endoscopy, knowing that the protests by the endoscopists would delay the regulation.
New information received as this article was going to press indicates that there will be new regulations requiring pulse oximetry in recovery rooms and making all existing standards apply equally to free-standing outpatient facilities.
To the ASA motto, “Vigilance’ can be added the word “Perservenance”. In order to get the regulation passed, it was necessary to deal with two administrations of the State Department of Health. Further, the concept was advanced without active support by some of those most likely to benefit, namely the insurers of New Jersey anesthesiologists and the New Jersey Hospital Association.
Special recognition should be given to Mr. Ned Weisfeld, of the Department of Health, who was able to assimilate all the relevant information and who refused to bend under the pressures of those interests that wanted the regulation weakened or even tabled.
The N.I.S.S.A. has trained the New Jersey Department of Health inspectors and plans to provide volunteer anesthesiologists to assist in the inspection process. Hopefully, as in Massachusetts, New Jersey wig see a decrease in mortality and morbidity and eventually, a decrease in anesthesia premiums for its anesthesiologists. To date, the two major New Jersey insurers, contrary to Massachusetts insurers, have taken a wait and see position on premium reduction.
This summary of the history of the regulation omits the mountains of correspondence by interested parties such as the Hospital Association, the N.I.S.S.A. and the Directors of all the anesthesia departments in New Jersey who were required to answer and in-depth survey developed by the state giving opinions on the proposed standards. Cooperation was unually good (especially compared with other specialties and this helped us by showing the state the unusual support for the regulation by anesthesiologists).
A complete bibliography was given to the New Jersey Department of Health. Included were the Massachusetts experience with the adoption of the Harvard Standards and the American Society of Anesthesiologists’ standards passed in 1986. Papers on capnography and oximetry were sent to the Director of the License Reform Project. The Witcher analysis from Stanford in the Journal of Clinical Monitoring with its detailed suggestion of cost savings to the hospitals having standards in place was submitted, as well as publications on how to finance the required improvements.
At the early meetings with the Department of Health, the original objectives of the N.I.S.S.A. to establish machine standards and monitoring standards were expanded by the state to include every facet of anesthesia care. At one point, the mandating of mass spectometry and computer generated anesthetic records were put on the agenda by the state. The N.I.S.S.A. explained that the cost to hospitals might well defeat the regulation on these points and the computerized anesthesia record was not only expensive but a young technology that also had raised many legal issues. The latter was left to regulations to be passed in the 1990’s. Thus, through discussion and the obvious on-the-job education of state staffers, formulation of the standards was a process of give and take
The anesthesia care standards are under hospital licensing standards (N.I.A.C. 8.43B-18). The Department of Health, as discussed, broadened our original intent and included statements that required written policies to be reviewed annually and to at least include:
1. (P.A.C.U. Standards) The P.A.C.U. standards are to be written as a separate part of a licensure reformed project and are currently being discussed.
2. “Monitoring of patients in any special procedure rooms where patients receive anesthesia:’ These monitoring standards include endoscopy rooms. After passage of the regulations, many anesthesia chairmen protested their unwanted and unrewarded involvement in the endoscopy suites. However, the N.J.S.S.A. felt that through this regulation the anesthesiologist could now have legitimate input into endoscopy suite practices by mandating standards of monitoring, credentialing, and record-keeping.
The N.J.S.S.A. since 1977 has attempted to alert malpractice carriers of the dangers of Valium and in later years, Versed. Dr. Moss, after the Versed deaths were reported in the press, was successful in having both New Jersey malpractice carriers publish warnings concerning Versed. Now through regulation, in the interest of patient safety, the expertise and knowledge of the anesthesiologist must be accepted by the endoscopist. It is understood that there may be a medical-legal risk in having standards to which anesthesiologists contributed but have little power to enforce. However, through Q.A. review of complications in endoscopy suites, Q.A. evaluation of record-keeping, and credentialing, hospital Executive Boards and eventually Boards of Trustees would be led to the obvious decision that monitoring equipment and record-keeping do not replace the missing anesthesiologist, C.R.N.A., or trained observer that has been (in the vast majority of cases) kept out of the endoscopy rooms.
Reporting Morbidity and Mortality
Notification of the New Jersey Department of Health within 24 hours and written confirmation within 30 days is required for all deaths and unexpected, severe intraoperative or postoperative untoward events or outcomes related to anesthesia. The written report shall include a summary of the incident and the patient’s ASA physical status. AU reports are guaranteed confidential. The reporting process will be evaluated 13 months after implementation.
The reporting mechanism is one of the demands of the Department of Health. A recent series of anesthesia mishaps in a New Jersey hospital received wide publicity, caught the state unaware of the problem, and therefore led to this part of the regulation as a method to prevent future embarrassment to the state. Although protested by many anesthesiologists and hospitals, it is not unreasonable that the Department of Health he involved in a Q.A. study that would give them data on mortality and morbidity and thus the trends of anesthesia mishaps.
Anesthesia Staff Qualifications for Administering Anesthesia
The regulation reads: “There shall be a Physician Director of Anesthesia Service who is a diplomats of either the American Board of Anesthesiology or the American Osteopathic Board of Anesthesiology or who was made a Fellow of the American College of Anesthesiology before 1972.”
Only two physicians in New Jersey will retain their Chairmanship under the 1972 Fellow of the American College of Anesthesiology clause.
Also, anesthetic agents including IV conscious sedation shall be administered in operating suites, obstetrical suites, endoscopy room, and any other anesthetizing location only in accordance with medical staff policies and procedures that specify who may administer anesthesia and under what conditions. The regulation defines IV conscious sedation: “it shall consist of the proper administration of drugs to obtund or dull or reduce the intensity of pain and awareness without loss of defensive reflexes.”
This section also defines who may administer anesthetic agents other than local or IV sedation. Administration is limited to:
2. A C.R.N.A. with current certification by A.A.N.A.
3. A registered nurse anesthetist who is a qualified candidate for certification provided that no national examination for such certification has been administered since the nurse became a qualified candidate for certification. The C.R.N.A. therefore must pass the first exam given and cannot practice as a C.R.N.A. if the exam is failed.
4. For clinical cases only, a dentist who has successfully completed a nationally approved program of anesthesia training.
5. A dental resident participating in a nationally approved graduate medical education training program in anesthesiology.
The regulation requires an anesthesiologist, anesthesia resident, or C.R.N.A. to be continuously present in the O.R. to monitor the patient and provide anesthesia care whenever a patient is receiving any anesthesia.
Important, too, was the requirement for the administrator of a local block or IV sedation to be continuously present in the O.R. or other anesthetizing location to monitor the patient. Except for local blocks and minor procedures performed in special procedure rooms, anesthesia shag not be administered by the individual who is performing the surgical procedure
The endoscopist in a special procedure room is permitted to administer IV sedation. Dr. Moss requested that the word “minor” before procedure be admitted, since an endoscopy is not always a minor procedure However, the rule does prevent an obstetrician, for example, from performing his own spinal and then operating as has occurred in New Jersey with tragic results.
“An anesthesiologist shall be on-site or on-call and available to reach the hospital within 30 minutes under normal transportation conditions at all times” The New Jersey Hospital Association wanted “normal transportation conditions” omitted thus requiring 24 hour in-house anesthesia coverage.
Many of our smaller hospitals in New Jersey do not have an O.B. department or emergency volume that warrants a 24 hour in-house anesthesiologist. It was successfully argued that the ASA and the A.C.O.G. joint statement permitted a 30 minute response time
Anesthesia Supplies and Equipment Safety Systems
This section requires the replacement or, if possible, the updating of all anesthesia machines in the state that do not meet the standards. Although criticized as being too simplistic, the various requirements mean that newly ordered machines must be built with technology now available. Included are:
1. An oxygen failure protection device (or “fail-safe” system).
2. A vaporizer exclusion (interlock) system.
3. No vaporizer shall be placed in the circuit downstream of the oxygen flush valve.
4. AU anesthesia vaporizers shall be pressure compensated.
5. Accurate flow meters and controllers must be on the machine.
6. Alarms for high and low circuit pressure must be on the machines.
7. Protocols to assure that when technically feasible, surgery does not proceed when there are disabled alarms, depleted batteries, and inactive sensors, improperly positioned breathing circuit sensors, or other insufficiencies.
Hospitals must have the mandated equipment in place within six months or show proof of ordering it. The Department of Health required a six month deadline while the N.I.S.S.A. recommended that one to two years was a more reasonable period of time, especially for the replacement of anesthesia machines. The Department of Health also requires availability of a backup system in case a capnograph or oximeter becomes nonfunctional. The State will compensate the hospital for the purchase of an additional capnograph and oximeter to be available for replacement. In the case of a central mass spectrometer, the Department of Health will reimburse hospitals for updating the in-room monitors to be capable of analyzing end tidal C02 when the mass spectrometer is down. The N.I.S.S.A. originally used the words “when technically feasible” intending that, in the case of a nonfunctioning monitor, the schedule could continue while the unit was repaired. In the Massachusetts regulations, 72 hours is permitted for repair. In New Jersey, each hospital must have a backup unit for oximetry and -capnography
Anesthesia Supplies and Equipment
Maintenance and Inspection This requires records (including machine identification, name of the service person, work performed, and date of work) be maintained for all service and maintenance of all machines, ventilators, and vaporizers. Credentials of each servicing person shall be approved by the machine manufacturer or determined by the physician director of the department of anesthesia to be equivalent to the credentials of the manufacturer’s service person.
Previously, some hospitals used in-house techni6ans or uncredentialed service companies to service anesthesia machines. Because of product liability the manufacturers have rules on who can service their machines and to whom they will sell their parts. The result is that many small companies who have been selling anesthesia service contracts and have been using uncredentialed repair personnel will no longer be able to do so. The chiefs of all New Jersey hospitals have received a statement of policy from both Ohmeda and Drager. The chiefs of the departments are responsible if they certify any individual who does not meet the criteria as spelled out by the manufacturers.
The regulation re-quires inspection of all equipment at the beginning of each day, with documentation. A check list developed by the manufacturer, the FDA, or by the hospital’s anesthesia service and approved by the hospital’s director of anesthesia, must be used.
All anesthesia equipment shall be inspected before each use and a record included on the patient’s anesthesia record. The record may consist of a single phrase or check mark in a box on the form.
The monitoring required in New Jersey includes:
1 .Oxygen analyzer
2. Respirometer (volumeter)
3. Body temperature monitoring
4. Pulse oximetry
6. EKG monitoring
7. Blood pressure monitoring
8. Pulse rate monitoring
9. Respiratory rate
In the case of blood pressure pulse and respiratory rate, they should be noted at minimum every five minutes for all patients receiving anesthesia in any anesthetizing location including the endoscopy room.
10. The capacity for invasive monitoring of arterial pressure shall exist within the operating room suite
11. A precordial stethoscope or esophageal stethoscope shall be used. If necessary, the stethoscope may be positioned on the posterior chest wall or tracheal area.
12. A peripheral nerve stimulator shall be available within the O.R. suite and in the P.A.C.U.
This section (along with the anesthetic machine standards) was the principal objective of the N.I.S.S.A. That Massachusetts has experienced no hypoxic deaths since early 1988 confirms the benefits of mandating oximetry and capnography. The temperature monitoring was originally left to the availability of monitors as in the ASA standards, but was changed to be mandatory after questioning of the ASA standard by the N.I.S.S.A. Committee As a result of discussion with Dr. Henry Rosenberg of the Malignant Hyperthermia Foundation, the state felt that this simple and inexpensive form of monitoring should be included and the Committee of the N.I.S.S.A. agreed. Availability of the capacity to monitor arterial pressure in the O.R. would permit a single portable unit to be available in the smallest of hospitals while the relatively inexpensive peripheral nerve stimulators was an obvious asset in both the O.R. and in the P.A.C.U. EKG monitoring is meant as a requirement for all anesthetics, i.e. general, regional and I.V. conscious sedation.
Also covered by the regulation are the areas of anesthesia patient services, staffing, staff education and training, and quality assurance. This latter section includes the mandatory reporting requirements for all anesthesia tragedies as discussed previously. No objection was raised by the N.I.S.S.A., which recognized that this would be the states quality assurance data base.
Of the first 31 hospitals surveyed by Ohmeda, only five would meet the standards. Obsolete anesthesia machines are more common than suspected. Entire O.R. suites are equipped with machines capable of delivering pure nitrous oxide, jerry-rigged with vaporizers outside the circle system, still having copper kettles in use, and vaporizers without interlock systems. Some hospital administrators are delaying the ordering of new equipment in the hope that the state will reimburse for new machines. At present, the state will reimburse for capnography, oximetry and for backup monitors. Reliable sources confirm that some hospitals will refuse to obey or attempt to delay the regulation and Dr. Moss has begun to question the state as to its plans for enforcement. The N.I.S.S.A. feels that failure to comply should not only result in a monetary fine but also closing of operating rooms until standards are met. As a last drastic 4peaswr-, newspapers could be given a press release by the N.I.S.S.A. on the standards listing those hospitals that have not complied after six months. If New York City restaurants fading Health Department inspections are listed in the newspaper each week, why not the same for hospitals?
The other pressure brought by a few hospitals is to instruct the anesthesiologists to purchase the machines and monitors themselves. This is completely unacceptable to the N.I.S.S.A. because surgeons do not purchase their instruments, ophthalmologist their microscopes, or radiologists their CT scanners. Although we hope that it will not be necessary, the N.J.S.S.A. will give legal support to any department that is put under such pressure.
Dr. Moss is a member of the East Jersey Anesthesia Group, Elizabeth, NJ and Chairman of the N.J.S.S.A. Ad Hoc Committee on Anesthesia Monitoring and Machine Standards. Also, Dr. Moss is the 1989 recipient of the prestigious Edward J. III Award from the Academy of Medicine of New Jersey, an annual award given for dedication and extraordinary service to the profession and to the citizens of New Jersey.