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June 1997
Volume 61 |
Number 6
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Practice Options:
Flying Without a Net: Office-Based
Anesthesia in the '90s |
Ervin Moss, M.D.
In this and following issues, the ASA NEWSLETTER will
be publishing articles about some of the various practice options
available to anesthesiologists today -- inside the operating room
and in other venues.
Much is to be learned by anesthesiologists from Mary Schiavo's
recently published book, Flying Blind, Flying Safe, which
disclosed the failure of the Federal Aviation Administration (FAA)
to inspect, police and enforce safety standards in the airline
industry preceding the Value Jet tragedy one year ago. As former
Inspector General of the Department of Transportation, Ms. Schiavo
warned of antiquated equipment, poor maintenance, counterfeit
parts, violation of codes and regulations, obsolete traffic control
systems and perfunctory review of pilots' credentials. For her
courage in exposing the failure of a government agency to ensure
the safety of the flying public, she has been branded a whistle-blower!
The practice of anesthesiology has often been compared to the
aviation industry. The anesthesia simulator is based on simulators
used in pilot training and recertification. Passengers entrust
their lives to a pilot and the airplane's equipment while patients
entrust their lives to anesthesiologists and their equipment in
the operating room. Both are usually unknown to passenger and
patient. The pilot and anesthesiologist rely on training and continuing
education. Both require preventive maintenance of their equipment,
calibration of instruments and monitors, and repairs by others.
The black box on an aircraft preceded the anesthesia automated
record keeper. Yet the black box on TWA 800 was obsolete and failed
to record the crucial last seconds.
What is the price of a human life or what is the price of the
avoidance of any anesthetic death? Pan Am 103 lawsuits cost $1
billion to settle, but it would cost $5 billion to prevent another
Pan Am 103! Enough said!
Yet there are those who argue against office standards using
cost as the argument. In reality, the $2,500 pulse oximeter or
the $15,000 refurbished anesthesia machine spread over years of
use and thousands of patients make the per-patient cost insignificant.
Just as passengers are willing to board discount airlines under
the misconception that if they are licensed they are safe, patients
are willing to be operated on in offices under the assumption
that some authority or some agency somewhere must be regulating
and must be responsible for the quality of the surgery, the anesthesia
and the staff. Sadly, except in a few states, this is not the
case.
Physician entrepreneurs have recognized the loophole in most
state regulations that fail to address the single operating room
within an office. Accordingly, there has been a proliferation
of locations in which surgery with anesthesia is performed without
any credentialing, peer review, physical plant and equipment standards,
or accountability.
Who would expect that 18 deaths in children from conscious sedation
out of 55 occurred in MRI units? Thirty additional deaths in the
series were in dental offices, according to Charles J. Coté,
M.D., an advocate for anesthesia standards in office-based settings.
The "New Jersey Experience" in its attempt to regulate
offices was detailed in the Winter 1996-97 issue of the Anesthesia
Patient Safety Foundation Newsletter. Since then, two more
office deaths have occurred without publicity in New Jersey, and
one that occurred in a dermatologist's office is under investigation.
Once again, it takes a tragedy to bring action, and the state
regulation titled "Surgical and Anesthesia Standards in Physicians'
Offices," created by the New Jersey State Society of Anesthesiologists
(NJSSA), is now promised for publication in the New Jersey
Register in May with a hearing in June 1997.
The opposition's ranks have swelled and now include a prestigious
attorney in the health care industry who accused the hospitals
of being behind the regulation in order to force operations back
into the hospital and who contend that enforcement of regulations
will drive up the cost of health care. Even the Food and Drug
Administration's requirement on anesthesia machine inspection
at the start of each day and before each case has been targeted
as being excessive. The reality is that an office operating room
is a business, and the cost of doing business includes costs to
properly construct, equip, maintain and staff the facility. If,
after expenses, there is no profit, then the business should not
exist!
Just as pilots have economic pressures to fly an unsafe plane
if they want jobs, anesthesiologists are under economic pressure
to accept work in offices that do not meet the conditions that
they had worked under in hospitals. Before accepting an office
position, the anesthesiologist should evaluate the physical plant,
the anesthesia equipment, the monitors, the staffing, the scheduled
surgery, the capability and reputation of the surgeon, protocols
and policies at the facility. After doing so, ask yourself if
you would want a member of your family to undergo surgery and
anesthesia in that office? Better still, if possible, be involved
in the design, equipping, staffing and writing of policies and
procedures for the facility. An anesthetic is an anesthetic, no
matter where it is administered. The benchmark should be the hospital,
which is still the safest, albeit the most expensive, place to
undergo surgery.
The existence of regulations as exemplified by the Federal Aviation
Administration's performance does not in itself guarantee safety.
FAA inspectors failed to inspect landing gear, oxygen systems
and engine controls half the time during inspections. In 1995,
Value Jet was denied a Defense Department contract and declared
unsafe for Defense Department personnel, but the airline was approved
for the general flying public.
National Fire Protection Association-99 (1996 edition) codes,
if enforced, would assure patient safety related to our medical
gas supply, yet only one state mandates its use. All new construction
of office operating rooms should, at a minimum, meet the most
recent NFPA Codes. The Joint Commission on Accreditation of Healthcare
Organizations addresses our gas sources; yet in a recent survey
by the NJSSA, 89 percent of the doctors surveyed had never been
questioned by the Joint Commission during an inspection about
medical gases. Sixty-seven percent did not know where the main
shut-off valve for oxygen in the hospital was located, and 48
percent did not have a protocol for the emergency loss of gases,
which is a Joint Commission requirement.
If this is the state of affairs within our licensed hospitals,
what can we expect to find in the office setting? Even when consultants
are used, their advice is not always correct. One superbly constructed
center was found to be short the required square feet of space
when the second operating room was approved. Since it was located
within an office building, expansion was not possible. A design
consultant informed me that it was not uncommon to find office
pipeline systems improperly designed, improperly installed, improperly
brazed and lacking alarms and shut-off valves. An industry source
advised me that the anesthesia machines classified as obsolete
in the 1989 New Jersey Hospital Anesthesia Regulations are now
being sold to offices in New Jersey for approximately $5,000.
If passed, the New Jersey Office Regulation will establish the
same safety features in anesthesia machines as defined in the
1989 Hospital Anesthesia Regulation. That regulation found approximately
250 of the 500 anesthesia machines in use, dating back to the
1950s, obsolete by criteria set by the NJSSA. What can we expect
to find in offices?
Physicians are traditionally antiregulation, and they often view
all attempts at regulation as an invasion of their professional
individuality. However, the regulations as proposed in New Jersey
would establish a baseline for patient safety when surgery with
anesthesia is performed in an office. Obviously, there is a need
for an authority to set and enforce standards as evidenced by
mortality in offices.
Fortunately, there is recognition by established credible hospital-based
anesthesia groups of the market for their services in the office
operating rooms. Most have moved with caution by investigating
the risks, benefits and demands of the new venue. They are contributing
their expertise to quality patient care and are improving the
image of the often marginal anesthesia provider who in years past
staffed the offices.
Finally, just as the FAA has been reorganized and the public
made aware of its inadequacies, organized anesthesiology has begun
to identify this weak link in patient safety that could diminish
the safety record achieved over the last two decades. The Society
for Office-Based Anesthesia was organized in the last year. The
Society for Ambulatory Anesthesia, too, has identified the office
as a new venue in ambulatory care. The practice of pain management
and office anesthesia warrant attention by other ASA component
societies. The NJSSA plans to create committees to address the
issue of both pain and office-based anesthesia.
The NJSSA, long committed to patient safety, has voted to purchase
an anesthesia patient simulator that can be used to update and
retrain anesthesiologists whose practice may be limited to offices.
The simulator will be programmed to teach advanced cardiac life
support, which is now a requirement for office anesthesia in New
Jersey.
Again, office-based anesthesia will explode in the next five
years. Its risks should not be minimized. Experienced, well-trained
anesthesiologists should encourage and, if necessary, demand that
every reasonable safety factor be incorporated into the office
operating room. The public expects and should receive no less!
Ervin Moss, M.D., practices part-time
at several ambulatory care facilities in central New Jersey, including
Ridgedale Surgery Center, SurgiCare of Central Jersey, Middlesex
Surgery Center, and Springfield Eye Surgery and Laser Center.
He is also Executive Medical Director of the New Jersey State
Society of Anesthesiologists, Princeton Junction, New Jersey.
E-mail the author.
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