Archive for the ‘Legislation’ Category

When you tell anyone in healthcare that “sedation” to the point of coma is given in dentists’ and oral surgeons’ offices every day, without a separate anesthesia professional present to give the medications and monitor the patient, the response often is disbelief.

“But they can’t do that,” I’ve been told more than once.

Yes, they can. Physicians are NOT allowed to do a procedure and provide sedation or general anesthesia at the same time – whether it’s surgery or a GI endoscopy. But dental practice grew up under a completely different regulatory and legal structure, with state dental boards that are separate from medical boards.

In many states, dentists can give oral “conscious” sedation with nitrous oxide after taking a weekend course, aided only by a dental assistant with a high school diploma and no medical or nursing background. Deaths have occurred when they gave repeated sedative doses to the point that patients stopped breathing either during or after their procedures.

Oral surgeons receive a few months of education in anesthesia during the course of their residency training. They are legally able to give moderate sedation, deep sedation or general anesthesia in their offices to patients of any age, without any other qualified anesthesia professional or a registered nurse present. This is known as the “single operator-anesthetist” model, which the oral surgeons passionately defend, as it enables them to bill for anesthesia and sedation as well as oral surgery services.

Typically, oral surgeons and dentists alike argue that they are giving only sedation – as opposed to general anesthesia – if there is no breathing tube in place, regardless of whether the patient is drowsy, lightly asleep, or comatose.

The death of Caleb Sears

Against this backdrop of minimal regulation and infrequent office inspections, a healthy six-year-old child named Caleb Sears presented in 2015 for extraction of an embedded tooth. Caleb received a combination of powerful medications – including ketamine, midazolam, propofol, and fentanyl – from his oral surgeon in northern California, and stopped breathing. The oral surgeon failed to ventilate or intubate Caleb, breaking several of his front teeth in the process, and Caleb didn’t survive.

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In the interests of full disclosure, I acknowledge with delight that I have a non-time limited board certificate from the American Board of Anesthesiology (ABA), issued before the year 2000. I can just say “no” to recertification.

The more I learn about the American Board of Medical Specialties (ABMS) and its highly paid board members, the more disillusioned I’ve become. It’s easy to see why so many physicians today have concluded that ABMS Maintenance of Certification (MOC) is a program designed to perpetuate the existence of boards and maximize their income, at the expense primarily of younger physicians.

Lifelong continuing education is an obligation that we accepted when we became physicians, recognizing that we owe it to ourselves and our patients. That is not at issue here. We have an implicit duty to read the literature, keep up with new developments, and update our technical skills.

The real danger of MOC is this:  It is rapidly evolving into a compulsory badge that you might soon need to wear if you want to renew your medical license, maintain hospital privileges, and even keep your status as a participating physician in insurance networks. If physicians don’t act now to prevent this evolution from going further, as a profession we will be caught in a costly, career-long MOC trap. The only other choice will be to leave the practice of medicine altogether, as many already are doing.

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Six-year-old Caleb Sears:  His death was preventable

I’m not a pediatric anesthesiologist. Most of us in anesthesiology – even those who take care of children in the operating room or the ICU every day – probably will never give anesthesia to a child in a dentist’s or oral surgeon’s office. So why should we care what happens there? Dental anesthesia permits and regulations, after all, are under the authority of state dental boards, not medical boards.

The reason we should care is that healthy children have died under anesthesia in dental office settings, children like Marvelena Rady, age 3, and Caleb Sears, age 6. Unfortunately, they aren’t the first children to suffer serious complications or death in our state after dental procedures under sedation or general anesthesia, and unless California laws change, they won’t be the last.

In 2016, officers and past presidents of the California Society of Anesthesiologists (CSA) have made multiple trips to meetings of the Dental Board of California (DBC) to discuss pediatric anesthesia. We’ve provided detailed written recommendations about how California laws concerning pediatric dental anesthesia should be updated and revised. We’ve explained in testimony before the Dental Board, and in meetings with lawmakers, why we believe so strongly that the single “operator-anesthetist” model (currently practiced by dentists and oral surgeons in many states) cannot possibly be safe.

The DBC on December 30 published new recommendations for revision of California laws pertaining to pediatric dental anesthesia, posted them on its website, and sent them to the Senate Committee on Business, Professions, and Economic Development. But these recommendations ignored many of our concerns, and don’t go nearly far enough to protect children.

Further, the DBC cites statistics claiming that pediatric dental anesthesia is currently safe. But there is no database! The Dental Board has admitted to discarding records after review. They have reported on “only nine” recent cases involving death, ignoring other tragic cases of permanent brain damage and prolonged ICU admissions. Pediatricians in California recently surveyed 100 of their members and found that 29 of them — nearly one-third — knew of patients in their practices who had experienced adverse events in a dental office.

What is a single “operator-anesthetist”?

You may never have heard of a single “operator-anesthetist” because such a thing doesn’t exist in medical practice.

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You may have read about the recent tragic deaths of two healthy children – Marvelena Rady, age 3, and Caleb Sears, age 6 – in California dental offices. Unfortunately, they aren’t the first children to die during dental procedures, and unless things change, they probably won’t be the last.

State Senator Jerry Hill has asked the Dental Board of California (DBC) to review California’s present laws and regulations concerning pediatric dental anesthesia, and determine if they’re adequate to assure patient safety. Assemblymember Tony Thurmond has sponsored “Caleb’s Law”, seeking improved informed consent for parents.

On July 28, I had the opportunity to attend a stakeholder’s meeting at the Department of Consumer Affairs in Sacramento, to hear a presentation of the DBC’s report, and to be part of the delegation offering comments on behalf of the California Society of Anesthesiologists (CSA). We hope this is the beginning of some long overdue upgrades to the current regulations.

By long-standing California state law, dentists and oral surgeons are able to provide anesthesia services in their offices even for very young children or children with serious health issues. They may apply for one of four different types of permits for anesthesia:

General anesthesia

Adult oral conscious sedation

Pediatric oral conscious sedation

Parenteral conscious sedation.

But the route of administration – oral or intravenous – isn’t the point, especially for small children, and oral sedation isn’t necessarily safer. Sedation is a continuum, and there is no way of reliably predicting when a patient will fall asleep. Relaxation may turn into deep sedation, and deep sedation into a state of unresponsiveness which is equivalent to general anesthesia. Oral medications have led to deaths in children, sometimes even before the dental procedure has begun or well after it has finished. There’s no logic in California’s lower standards of emergency equipment and monitoring for procedures done under sedation as opposed to under general anesthesia.

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When Arnold Schwarzenegger was governor, he decided that you and I don’t need to have physicians in charge of our anesthesia care, and he signed a letter exempting California from that federal requirement. Luckily most California hospitals didn’t agree, and they ignored his decision.

When he needed open-heart surgery to replace a failing heart valve, though, Governor Schwarzenegger saw things differently. He chose Steven Haddy, MD, the chief of cardiovascular anesthesiology at Keck Medicine of USC, to administer his anesthesia.

Now some people in the federal government have decided that veterans in VA hospitals all across the US should not have the same right the governor had—to choose to have a physician in charge of their anesthesia care.

That’s right. The VA Office of Nursing Services has proposed a new policy to expand the role of advanced practice nurses, including nurse anesthetists, in the VA system. This new policy in the Nursing Handbook would make it mandatory for these nurses to practice independently. Physician anesthesiologists wouldn’t be needed at all, according to this proposal, even in the most complicated cases – such as open-heart surgery.

If this misguided policy goes into effect, the standard of care in VA hospitals will be very different from the standard of care other patients can expect. In all 100 of the top hospitals ranked by US News & World Report, physician anesthesiologists lead anesthesia care, most often in a team model with residents and/or nurses.

The new policy isn’t a done deal yet. The proposal is open for comment in the Federal Register until July 25. Already thousands of veterans, their families, and many other concerned citizens have visited the website www.safeVAcare.org and submitted strongly worded comments in opposition. I urge you to join them.

Physician-led care teams have an outstanding record of safety, and they have served veterans proudly in VA hospitals for many years. Many university medical centers have affiliations with their local VA hospitals, where their faculty physicians deliver clinical care and conduct research. UCLA, for example, sends anesthesiologists to the VA hospital in Los Angeles, so that our veterans get the same high-quality care as wealthy patients from the enclaves of Brentwood.

Many of our veterans aren’t in good health. They suffer from a host of service-related injuries, and they have high rates of chronic medical disease. Some have been among the most challenging patients I’ve ever anesthetized. Their care required all the knowledge I was able to gain in four years of medical school, four years of residency training in anesthesiology, and countless hours of continuing medical education.

No VA shortage of anesthesia care

It’s clear, of course, why the VA is proposing the change in the Nursing Handbook. The reason is the scandal over long waiting times for primary care. Proponents argue that giving nurses independent practice will expand access to care for veterans.

But there’s no shortage of physician anesthesiologists or nurse anesthetists within the VA system. The shortages exist in primary care. A solution that might help solve the primary care problem shouldn’t be extended to the complex, high-tech, operating room setting, where a bad decision may mean the difference between life and death.

The VA’s own internal assessment has identified shortages in 12 medical specialties, but anesthesiology isn’t one of them. The VA’s own quality research questioned whether a nurse-only model of care would really be safe for complex surgeries, but this question was ignored. The proposed rule in the Federal Register lists as a contact “Dr. Penny Kaye Jensen”, who in fact is not a physician but an advanced practice nurse who chooses not to list her nursing degrees after her name. The lack of transparency in the proposal process is disturbing.

In 46 states and the District of Columbia, state law requires physician supervision, collaboration, direction, consultation, agreement, accountability, or direction of anesthesia care. The proposed change to the VA Nursing Handbook would apply nationally and would override all those state laws, which were put in place to protect patients.

In Congress, many senators and representatives on both sides of the aisle recognize the need to continue physician-led anesthesia care for veterans. Representatives Julia Brownley of California’s 26th District and Dan Benishek, MD, of Michigan’s 1st District are strong advocates for veterans’ health. They have co-authored a letter (signed by many in Congress) to VA Secretary Robert McDonald, urging him not to allow the destruction of the physician-led care team model as it currently exists within the VA system.

Governor Schwarzenegger’s heart surgery is a matter of public record. He has spoken about it openly on television, and he graciously invited the whole operating room team to his next movie premiere. I was lucky enough to go to the premiere too, because his anesthesiologist, Dr. Haddy, happens to be my husband.

But I didn’t set out to write this column on behalf of my husband. I’m writing on behalf of my father, who is now 93, landed on the beach at Normandy on D-Day, and miraculously survived the rest of the war as a sniper. And I’m writing on behalf of all the men and women who have served our country, and who deserve the best possible anesthesia care from physicians and nurses who want to work together to take care of them. If we don’t defeat the proposed change in the VA Nursing Handbook, they all lose.

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