August 1998
Volume 62 |
Number 8
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| Revelations: New
Jersey Office Regulations Adopted |
Ervin Moss, M.D., Executive Medical Director
New Jersey State Society of Anesthesiologists
The New Jersey State Society of Anesthesiologists has waged
an almost 15-year battle to get state regulators to recognize
that patients receiving anesthesia in office-based settings deserve
the same protections they receive in hospitals or surgical centers.
Despite charges that such a regulation will drive up health care
costs, lower some physicians' "bottom line" and force the closing
of some physicians offices, New Jersey is the first state in the
country to adopt office-based anesthesia regulations. These regulations
became effective on June 15, 1998.
Not since Eve (or was it Adam, or the snake?) had the revelation
that their anatomical difference had significant implications
has there been a revelation concerning the difference between
office-based anesthesia safety and safety of the traditional anesthesia
administered in hospitals and ambulatory care centers.
There are those who claim that it takes a special breed
of anesthesiologist equipped with special techniques and drugs
to perform office-based anesthesia. Some say that the major difference
between the office-based and hospital-based anesthesiologist is
that the former must be more courageous or foolhardy. In the case
of some offices I have visited, the main difference is that one
must anesthetize a patient far removed from the support that exists
within the hospital or even within the multiroom surgical center.
Despite the movement toward office-based anesthesia and surgery,
the fact is, it is still safer today to administer anesthesia
within a hospital than in an isolated office often located in
a strip mall or deep within the bowels of an office complex.
As one who trained in administering open drop ether, ethylene
and cyclopropane some 43 years ago, I admit being from the "Old
School" that developed a great respect for the dangers and potency
of the drugs used then and those now being used, and therefore,
I have actively been a proponent of risk management through mandatory
monitoring, updated anesthesia machines and regulations.
The revelation about the risks of office surgery and anesthesia
came to me following the death of a 16-year old girl undergoing
an abortion in an office setting in 1984. A letter was sent immediately
to the New Jersey Board of Medical Examiners warning of the dangers
of office surgery and anesthesia and predicting the proliferation
of office operating rooms. It was ignored, as was my appeal to
regulate Valium in 1977 and Versed in 1987 after numerous reports
of death from conscious sedation. One success was the five-year
task in establishing Hospital and Licensed Surgicenter Regulations
in 1989-1990, which included credentialing for conscious sedation.
This regulation has yet to be duplicated by any state and, in
fact, makes up the format of the office-based regulation because
it is our concept that quality of anesthesia care should not vary
because of the location in which the anesthesia is administered.
The last shoe to drop that caught the attention of the
New Jersey Board of Medical Examiners involved two deaths in the
same dermatologist's office whose liposuction training is alleged
to have been a 30-minute videotape. Finally, on December 10, 1997,
the New Jersey Regulation on Office-Based Surgery and Anesthesia
was adopted by the New Jersey Board of Medical Examiners with
few changes as published in the New Jersey Register on
May 19, 1997. Deputy Attorney General Sharon Joyce was then required
to answer every comment made during the comment period. The few
minor changes had to be incorporated into the body of the text,
and the final version was scrutinized carefully by the Office
of Administrative Law. The final rule adoption was effective as
of June 15, 1998.
The crux of the need for this regulation, as evidenced
by such examples as the liposuction death, was credentialing.
The initial intent of the Board of Medical Examiners' committee
of multispecialists was to regulate only anesthesiology since
it was the anesthesiologists pushing for regulation. Then the
realization hit that one cannot separate the practice of surgery
from the practice of anesthesiology when drafting office regulations.
The result was the obligatory credentialing of surgeons and anesthesiologists
practicing office surgery.
The requirement that a surgeon or anesthesiologist be
credentialed in a hospital to perform the procedures he or she
performs in the office was met with protests. Some surgeons and
anesthesiologists do not desire to belong to hospital staffs and
only intend to practice within their own offices. Such settings,
however, are free of peer review, peer pressures, quality assurance,
quality improvement and are, in fact, free of all regulations
found in licensed institutions.
The result was the development of an alternate route of
credentialing under the New Jersey Board of Medical Examiners.
Those wishing only to perform conscious sedation will be credentialed
in a similar fashion as developed by hospitals to satisfy the
credentialing criteria of the Joint Commission on Accreditation
of Healthcare Organizations. Those wishing to perform general
and regional anesthesia will also be credentialed by the Board
in a yet-to-be-announced method.
Of note is that nurse anesthetists do not need to be credentialed.
Recertification of a nurse anesthetist is based on continuing
education credits, not examinations, and the Board accepted that
since all anesthesia must be supervised by an anesthesiologist
or physician credentialed in conscious sedation, separate credentialing
of nurse anesthetists was not necessary.
New Jersey requires that nurse anesthetists be supervised
by an anesthesiologist in hospitals and licensed surgical centers
with two or more rooms; thus, the revelation came to Deputy Attorney
General Joyce drafting the regulations that since supervision
by anesthesiologists for general and regional anesthesia and by
a credentialed physician for conscious sedation is required in
hospitals, should not the same requirements be mandated for the
less safe office operating room?
At the public hearing held on June 4, 1997, the nurse
anesthetists came in force with their lawyers to protest what
was already in effect for hospitals and licensed surgical centers.
In answer to the protests, one statement came forth from the Deputy
Attorney General that was a revelation to the CRNAs and the uninformed
in the audience. It was: "Anesthesia in New Jersey is the practice
of medicine."
I have suggested that this be engraved in stone and placed
at the American Society of Anesthesiologists (ASA) Executive Office
along with another revelation stated by the State of New York
Department of Health's Council and Committee on Quality Assurance
in Office-Based Surgery in an invitation to speak at a public
hearing on office surgery on May 4, 1998: "Given that all patients
are entitled to quality surgical care and services regardless
of the setting of such surgery (i.e., hospital, ambulatory surgery
center or office), is the establishment of a single standard of
care for all settings necessary to achieve a satisfactory level
of quality assurance?"
If by chance there are more slabs available, the following
may be inscribed dealing with enforcement of the regulations:
"Any violation of N.J.A.C. 13:35-4A - 4A.17 shall
be deemed professional misconduct ... and may further constitute
violation of other laws or rules as applicable to the circumstances."
In response to the allegation of "antitrust violation"
voiced by the American Association of Nurse Anesthetists, the
Board's reply was:
"There is no statutory or judicial authority authorizing
independent CRNA [certified registered nurse anesthetist] practice
in New Jersey. ... The Board believes this direction to further
patient safety."
Another statement worthy of engraving is:
"There is no provision in the state which authorizes
independent practice of CRNAs. Anesthesia is the Practice of
Medicine and as such physician direction is required and appropriate."
Evidently both New Jersey Senators Frank R. Lautenberg
and Robert G. Torricelli are unaware of the current requirements
in New Jersey because both have taken a neutral position on the
proposal to permit nurse anesthetists to administer anesthesia
to Medicare and Medicaid patients without supervision of an anesthesiologist
or any physician.
There are 17 sections of the New Jersey Regulation, each
with subsections. The most important deal with 1) mandatory reporting
mechanism, 2) standards of surgery and anesthesia, 3) credentialing
(who can do what), 4) discharge criteria, 5) postanesthesia care
standards, 6) equipment requirements, 7) monitors and anesthesia
machine standards, and 8) preventative maintenance of machines
and monitors.
Nurse anesthetists will be required to be supervised in
an office to give general or regional anesthesia and by a physician
credentialed in conscious sedation for administration of drugs
for conscious sedation. Requirements of those who can monitor
conscious sedation other than a nurse anesthetist are also spelled
out.
There were supporters of the regulation who, in person
or in writing, expressed support, including ASA, the Society for
Ambulatory Anesthesia (SAMBA), the Society for Office-Based Anesthesia,
the New Jersey Department of Health and Princeton Insurance Company,
which is one of two major providers of professional liability
insurance. The Vice President of the Medical Society of New Jersey
stated, "These rules constitute one of the most significant reforms
initiated by the Board." However, in another letter, the officer
stated that given "the uniquely aggressive, unprecedented attempt
to impose elaborate and comprehensive regulatory controls on specific
specialties in a time of history change ... it should be required
to review the regulation in two years." Evidently, the Medical
Society of New Jersey forgot that its Board of Trustees voted
down support of the regulation in 1992.
The opposition was well-represented by nurse anesthetists,
plastic surgeons, dermatologists, ophthalmologists, radiologists,
abortion center representatives, gynecologists working in fertility
centers and even the New Jersey Hospital Association. A letter
supporting the regulation from the New Jersey Radiologic Association
requested 37 changes, including exclusion of conscious sedation
as anesthesia and exclusion of pediatric magnetic resonance imaging
(MRI) as requiring the standards set forth. Also, there was a
protest concerning "immediately available." Such opposition came
despite the death of an 18-month-old in New Jersey during an MRI
while sedated with rectal Pentothal and without monitoring or
trained personnel in attendance.
The abortion center representatives were verbal in expressing
fear that costs would rise. Nurse anesthetists are still able
to provide conscious sedation; the difference is that the supervising
gynecologist must now be credentialed to provide conscious sedation.
Cost seemed to be a common theme running through protests. Plastic
surgeons worried that the cost of meeting the regulations would
lower their bottom line and cause the closing of their offices.
This would leave countless New Jersey residents running around
with globs of fat hanging from thighs, stomachs, love handles,
chins and buttocks ... but still alive!
The Board, again "Solomon-like," stated:
"The Board has attempted to balance the financial impact
of these rules with the enhanced protection ... it does not
envision diminished access and expects enhanced quality of care.
...The enhancement of safety of the public is well worth any
additional expense. ...Certainly patients seeking elective plastic
surgery in an office-based practice are entitled to the same
protections as those offered to hospital patients."
What helped to assist the Board of Medical Examiners in
these strong statements was the death of a patient in the office
of a plastic surgeon who himself sat on the Board and was a member
of the committee to set regulations for office-based surgery and
anesthesia.
In answer to another commenter who stated simply, "The
rules are unnecessary," the Board said:
"The Board disagrees and indeed it believes they are long
overdue - because patients in all medical settings deserve the
same level of protection."
The tone of this article may be that of bitterness. In
defense, people have died in offices in New Jersey because of
the "politics of patient safety" kept the New Jersey Regulation
on Office-Based Surgery and Anesthesia from being passed in a
timely fashion. I have spoken to the mother of a teenager who
died from a complication of liposuction. She weighed 110 pounds
before surgery. Her death and others were a horrible waste and
could have been prevented!
I am pleased that ASA is working on practice guidelines
for office-based anesthesia and that SAMBA has directed its attention
to the office components of ambulatory anesthesia. New York, Massachusetts,
Pennsylvania, Maryland, Connecticut and Michigan are beginning
to look at a problem that, in my opinion, has become a public
health issue. The Anesthesia Patient Safety Foundation (APSF)
has contacted SAMBA to contribute support, which pleases me since
I had attempted as a member of the APSF Board of Directors to
involve APSF in office safety for several years. SAMBA has answered
by becoming a contributing sponsor of APSF.
There were suggestions that accreditation by the Joint
Commission and the Accreditation Association for Ambulatory Health
Care be sufficient, as in California. The Board responded:
"These rules are not premised based, but focus on
the licenses over whom the Board has jurisdiction. The Board
has hereby placed obligations on its licensees to meet certain
standards which are largely comparable to those which these
accrediting bodies would recognize. The rule does more in [that]
it assures qualifications of practitioners."
These quotes, filled with wisdom, common sense and logic,
come from the pen and lips of Deputy Attorney General Joyce, who
was the constant throughout the many changes of Board members
over the many years. She is to be commended for separating the
wheat from the chaff, and in doing so, she has made an important
contribution to patient safety in New Jersey.
It is hoped that the New Jersey Regulation on Office-Based
Surgery and Anesthesia will be used as a benchmark by other states
contemplating regulations for office-based procedures.
Ervin Moss, M.D., is a practicing anesthesiologist
in central New Jersey.
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